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·|­û¡G¤Ñ©R10141925  µoªí®É¶¡:2019/12/5 ¤U¤È 03:14:54²Ä 1872 ½g¦^À³
Dupilumab ªvÀø ¤¤-­««×COPD¤T´ÁÁ{§É

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS)

clinicaltrials.gov/ct2/show/NCT03930732?term=Dupixent+%28dupilumab%29&draw=1&rank=20

Estimated Enrollment ƒÊ : 924 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

Actual Study Start Date ƒÊ : April 15, 2019

Estimated Primary Completion Date ƒÊ : January 2022

Estimated Study Completion Date ƒÊ : April 2022

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www.careonline.com.tw/2019/09/dermatitis.html

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Lebrikizumab AD ªº¤G­Ó¤T´ÁÁ{§É,¦@800¤H¦Ó¤w,¦Ó¥B

Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)

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1.

clinicaltrials.gov/ct2/show/NCT04146363?term=Lebrikizumab++AD&draw=1&rank=5

Evaluation of the Efficacy and Safety of Lebrikizumab in Moderate to Severe Atopic Dermatitis (ADvocate1)

Study Design

Go to sections

Study Type ƒÊ : Interventional (Clinical Trial)

Estimated Enrollment ƒÊ : 400 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, double-blind, parallel group, placebo controlled

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double-blind

Primary Purpose: Treatment

Official Title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

Actual Study Start Date ƒÊ : October 8, 2019

Estimated Primary Completion Date ƒÊ : June 2021

Estimated Study Completion Date ƒÊ : December 2021

2.Evaluation of the Efficacy and Safety of Lebrikizumab in Moderate to Severe Atopic Dermatitis (ADvocate2)

clinicaltrials.gov/ct2/show/NCT04178967?term=Lebrikizumab++AD&draw=1&rank=4

Study Design

Study Type ƒÊ : Interventional (Clinical Trial)

Estimated Enrollment ƒÊ : 400 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, double-blind, parallel group, placebo controlled

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double-blind

Primary Purpose: Treatment

Official Title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.

Actual Study Start Date ƒÊ : November 8, 2019

Estimated Primary Completion Date ƒÊ : June 2021

Estimated Study Completion Date ƒÊ : December 2021

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Lebrikizumab ¦³¤j°ÝÃD, ¥L©Û¦¬AD 1 ¦~ªvÀøµL®Ä±wªÌ.

°ò¥»¤WDuplimab , AD, FDA ®Ö·Ç , ¤T¦~ªvÀøµL®Äªº±wªÌ,¤~¥ÎDuplimab¥Íª«»s¾¯, ¦~ÃĶO36,000¬ü¤¸,

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©Û¦¬ >=1 ¦~ AD

A Study of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

Study Design

Study Type ƒÊ : Interventional (Clinical Trial)

Actual Enrollment ƒÊ : 280 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

Actual Study Start Date ƒÊ : January 30, 2018

Actual Primary Completion Date ƒÊ : February 7, 2019

Actual Study Completion Date ƒÊ : May 23, 2019

Criteria

Inclusion Criteria:

•Male or female, 18 years or older.

•Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .

•Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.

•Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.

•≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.

clinicaltrials.gov/ct2/show/NCT03443024

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Dermira Announces Initiation of Phase 3 Program Evaluating Lebrikizumab in

Patients with Moderate-to-Severe Atopic Dermatitis

- Two identical Phase 3 monotherapy studies expected to enroll a total of

approximately 800 adult and adolescent patients ages 12 and older

- Topline results from the 16-week induction period expected in the first half

of 2021

Business Wire

MENLO PARK, Calif. -- October 9, 2019

Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to

bringing biotech ingenuity to medical dermatology by delivering

differentiated, new therapies to the millions of patients living with chronic

skin conditions, today announced dosing of the first patient in a Phase 3

study evaluating the safety and efficacy of lebrikizumab in adult and

adolescent patients ages 12 and older with moderate-to-severe atopic

dermatitis, the most common form of eczema.

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind

IL-13 with very high affinity, specifically preventing the formation of the

IL-13R£\1/IL-4R£\ heterodimer complex and subsequent signaling, thereby

inhibiting the biological effects of IL-13 in a targeted and efficient

fashion. IL-13 is believed to be a central pathogenic mediator that drives

multiple aspects of the pathophysiology of atopic dermatitis by promoting type

2 inflammation and mediating its effects on tissue, resulting in skin barrier

dysfunction, itch, skin thickening and infection.

¡§The positive results of our Phase 2b dose-ranging study suggest specifically

targeting IL-13 with lebrikizumab has the potential to deliver a

best-in-disease therapy for people living with moderate-to-severe atopic

dermatitis,¡¨ said Tom Wiggans, chairman and chief executive officer of

Dermira. ¡§Our Phase 3 clinical program is designed to confirm those findings

and hopefully bring an important new treatment option to the millions of

people living with this chronic and often debilitating disease. We expect to

report findings from the 16-week induction period of the monotherapy studies

in the first half of 2021.¡¨

¡§The initiation of the Phase 3 study combined with the positive results of the

Phase 2b study underscore our confidence and excitement around the potential

of lebrikizumab for patients with moderate-to-severe atopic dermatitis,¡¨ said

Peter Guenter, chief executive officer of Almirall, Dermira¡¦s collaboration

partner in Europe. ¡§Almirall is fully committed to this partnership and to

offering breakthrough treatments, like lebrikizumab, that have the potential

to make a meaningful difference for patients living with severe skin

conditions.¡¨

Lebrikizumab Phase 3 Program

The lebrikizumab Phase 3 program includes two identical, randomized,

double-blind, placebo-controlled, parallel-group Phase 3 studies designed to

confirm the safety and efficacy of lebrikizumab as monotherapy in patients

with moderate-to-severe atopic dermatitis. The studies are expected to enroll

a total of approximately 800 adult and adolescent patients ages 12 years and

older with moderate-to-severe atopic dermatitis at approximately 200 sites in

the United States, Europe and Asia.

Key patient inclusion criteria for the monotherapy studies include the

presence of chronic atopic dermatitis for at least one year, an Investigator¡¦s

Global Assessment (IGA) score of 3 or 4 (on a 5-point scale ranging from 0 to

4), an Eczema Area Severity Index (EASI) score of 16 or greater and body

surface area (BSA) involvement of at least 10 percent at screening and

baseline.

The studies will evaluate a 250 mg dose of lebrikizumab administered by

subcutaneous injection every two weeks, following a loading dose of 500 mg

administered at baseline (day 0) and week 2, compared to placebo for 16 weeks

(the induction period). Following the end of the 16-week induction period,

study patients who respond during the induction period (as evidenced by

achievement of an IGA 0/1 response, representing a reduction of 2 or more

points in IGA score from baseline to a final score of 0 (clear) or 1 (almost

clear), or an EASI-75 response, representing an improvement in EASI score of

at least 75 percent from baseline) will be re-randomized to one of the

following treatment groups for an additional 36-week maintenance period:

* Group A: Lebrikizumab 250 mg given every two weeks;

* Group B: Lebrikizumab 250 mg given every four weeks; or

* Group C: Placebo given every two weeks.

Patients who do not achieve an IGA of 0/1 response or an EASI-75 response at

week 16 and patients who do not maintain an EASI-50 response during the

maintenance period will be assigned to receive lebrikizumab 250 mg as

open-label treatment every two weeks through week 52.

The primary efficacy endpoint of the studies is the percentage of patients

with an IGA 0/1 response from baseline to week 16.

Key secondary efficacy endpoints that will be evaluated during the 16-week

induction period include: the percentage of patients achieving EASI-75; the

percentage of patients achieving EASI-90; the percentage of patients with a

pruritus (itch) numerical rating (NRS) score of at least 4 at baseline who

achieve a reduction of at least 4 points; percentage changes in pruritus and

sleep-loss scores; and change in BSA.

The company expects to report topline findings from the 16-week induction

period in the first half of 2021. In addition to the two monotherapy studies,

the company plans to include a study in the Phase 3 program that evaluates

lebrikizumab when used in combination with topical corticosteroids. The impact

of lebrikizumab treatment on quality of life will also be assessed across a

number of additional measures.

www.bloomberg.com/press-releases/2019-10-09/dermira-announces-initiation-of-phase-3-program-evaluating-lebrikizumab-in-patients-with-moderate-to-severe-atopic-dermatitis

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¤é«e¡A¨È·à±d-KY¡]Aslam Pharmaceuticals¡^¤½¥q«Å¥¬¡A¸Ó¤½¥q¶}µoªº¹v¦VIL-13¨üÅé£\1¨È°ò¡]IL-13£\1¡^³æ§J¶©§ÜÅéASLAN004¡A¦bªvÀø¯SÀ³©Ê¥Öª¢¡]atopic dermatitis¡^ªº·§©ÀÅçÃÒ¸ÕÅ礤Àò±o¿n·¥µ²ªG

¯SÀ³©Ê¥Öª¢¬O³Ì¬°±`¨£ªº¥Ö½§¯e¯f¤§¤@¡A¥þ²y¦³¶W¹L¨â»õ¦W±wªÌ¨ü¨ì³o¤@¯e¯fªº§xÂZ¡C¯SÀ³©Ê¥Öª¢ªº¯gª¬¬°¥Ö½§¬õ¸~¡A¨Ã¦ñ¦³«ùÄòæ±Äo¡A¥i¯àÄY­«¼vÅT±wªÌªº¥Í¬¡½è¶q¡C°ª¹F¤T¤À¤§¤@ªº¦¨¤H±wªÌªº¯f±¡¹F¨ì¤¤«×¦Ü­««×¡C¹ï©ó¤j¦h¼Æ±wªÌ¨Ó»¡¡A±±¨î¯e¯f¯gª¬¤´µM¬O¤@­Ó¬D¾Ô¡C

ºI¦Ü¤µ¦~11¤ë29¤é¡A¦³6¦W±wªÌ±µ¨ü¤F³Ì§C¾¯¶qASLAN004ªºªvÀø¡C¸ÕÅçµ²ªGªí©ú¡A¦b3¦W¦Ü¤Ö±µ¨üªvÀø¤@­Ó¤ëªº±wªÌ¤¤¡A±wªÌÀã¯l­±¿n©MÄY­«µ{«×«ü¼Æ¡]Eczema Area and Severity Index, EASI¡^µû¤À»P°ò½u¬Û¤ñ¡A¤À§O­°§C¤F85%¡A70%¡A©M59% ¡CEASI¦b±µ¨üªvÀø«á²Ä4¶g¤´µM¦b«ùÄò¤U­°¡A¹w­p¦b±µ¨üªvÀø6-8¶g«á¹F¨ì³Ì¤jÀø®Ä¡C

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....IL-13 receptor (R) £\1 and are key pharmacological targets in fibrotic diseases. However, the roles of IL-13R£\1 in mediating lung injury/repair are unclear........ These data highlight underappreciated protective roles for IL-13R£\1 in lung injury and homeostasis...]

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Interestingly, we observed that the magnitude of STAT6 activation and gene expression induced by IL-4 in wild-type macrophages is generally greater than that induced by IL-13. These results are consistent with related findings by others [19, 20]

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www.transparencymarketresearch.com/asthma-treatment-market.html

Asthma Treatment Market: Increasing Penetration of Generic Drugs to Drive Sluggish Growth

The global asthma treatment market will rise from a value of ~US$ 25.6 Bn in 2019 to ~US$ 30.5 Bn by 2027, and it is anticipated that an increase in the number of FDA-approved products in parallel to the increasing awareness among asthma patients regarding quality care will drive the steady odyssey of the market.

Analysts at Transparency Market Research (TMR) anticipate that, among the strategic approaches taken towards consolidation, partnerships and collaborations will remain integral to maximize profitability from new markets. Having witnessed product recalls, manufacturers in the asthma treatment market are dedicating ample efforts to develop high-quality products, which are likely to receive easy approvals from the FDA and similar regulatory bodies.

On the demand side, as awareness regarding quality care for the treatment of asthma increases among patients, the adoption of inhalers and oral drugs is likely to increase. However, in recent times, the cost-benefits of generic drugs have been appealing to patients, which could pose as a challenge for manufacturers in the asthma treatment market.

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Atopic Dermatitis: Global Drug Market | Forecast to 2027

adminmarketby adminmarketƒeMarch 6, 2019

Summary:

Atopic Dermatitis is a widespread chronic inflammatory skin condition that can affect patients of all ages and is the result of a complex interplay of environmental, immunological, genetic, and pharmacologic factors. The atopic dermatitis market has historically remained stagnant and the pipeline for drugs in late-stage development was lacking, but recent developments have reignited interest in the treatment of the disease, especially as the estimated drug-treated population may grow to 24,000,000 people over the next decade.

In March 2017, Regeneron/Sanofi gained approval for Dupixent (dupilumab), the first-in-class interleukin (IL)-4 receptor inhibitor that has set a new gold standard in the treatment of atopic dermatitis. Moreover, a highly competitive and genericized topical market has pushed other pharmaceutical companies to develop their own systemic treatments, with a new class of therapies in development, Janus kinase (JAK) inhibitors, two of which have already been granted Breakthrough Therapy designation by the FDA. As a result, the atopic dermatitis market is set to become much more dynamic, with widening appreciation that atopic dermatitis is a highly variable disease and that not every patient will react in the same way to the same therapy. With existing unmet needs in the topical landscape for treatments that do not have side effects and for better understanding the pathophysiology and etiology of the disease, atopic dermatitis represents an attractive dermatology sector for drug developers. In turn, this will fuel commercial interest in this market.

Get Free Sample Report

According to research the sales of drugs in the atopic dermatitis market were approximately $6.4B in 2017 in the 7MM. The US was the largest market, with approximately $5.1B in drug sales, which represented 80% of the total atopic dermatitis market. The 5EU market contributed $1.1B in sales and Japan contributed sales of $202M in 2017.

Global sales in the atopic dermatitis market are expected to grow to $18.3B by 2027, at a Compound Annual Growth Rate (CAGR) of 11.1% from 2017-2027. Research report forecasts the US to grow to $13.6B (74.5% of global sales), the 5EU to grow to $4B (21.7% of global sales), and Japan to grow to $693M (3.8% of global sales) over the next 10 years.

marketresearchdistributor.com/2019/03/06/atopic-dermatitis-drug-market-analysis-and-forecast-to-2027/

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-------Overall, this growing body of evidence suggests that AD is an IL-13-, rather than IL-4-, driven disease...

CONCLUSION

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more expressed than IL-4 in lesional skin and is therefore one of

the key drivers in this condition. IL-13 has a large impact on the epidermal barrier function and the local immune response............]

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Dermira Announces Positive Topline Results from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis

March 18, 2019 07:00 ET | Source: Dermira, Inc.

- All three doses of lebrikizumab met primary endpoint with statistical significance

- Lebrikizumab was well-tolerated; safety profile consistent with prior studies

- Efficacy and safety profile support advancement into Phase 3; planned by end of 2019

- Conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT

MENLO PARK, Calif., March 18, 2019 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of people living with chronic skin conditions, today announced positive results from a Phase 2b dose-ranging study of lebrikizumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis. All three doses of lebrikizumab met the primary endpoint, demonstrating greater improvements in the Eczema Area and Severity Index (EASI) score compared to placebo. The safety profile for lebrikizumab observed in the study was consistent with prior studies evaluating this investigational therapy.

Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with high affinity, specifically preventing the formation of the IL-13R£\1/IL-4R£\ heterodimer complex, which inhibits downstream signaling. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.

¡§These data are compelling and further demonstrate clinically that IL-13 is a key mediator in atopic dermatitis,¡¨ said Emma Guttman-Yassky, M.D., Ph.D., The Sol and Clara Kest Professor, Vice Chair for Research in the Department of Dermatology, Director of the Center of Excellence in Eczema at Icahn School of Medicine at Mount Sinai and a leading study investigator. ¡§I have many patients for whom current therapies do not adequately address their needs. These data show that lebrikizumab may offer a targeted, effective and well-tolerated therapeutic approach.¡¨

About Lebrikizumab Phase 2b Study

Across all of the doses evaluated, lebrikizumab showed a dose-dependent and statistically significant improvement in the primary endpoint, the mean percent change in EASI score from baseline to week 16. The improvement in EASI score was 62.3% for patients receiving lebrikizumab, 125 milligrams (mg), every four weeks (p=0.0165), 69.2% for patients receiving lebrikizumab, 250 mg, every four weeks (p=0.0022) and 72.1% for patients receiving lebrikizumab, 250 mg, every two weeks (p=0.0005) compared to 41.1% for patients receiving placebo.

Patients treated with lebrikizumab at the 250 mg dose every two or four weeks achieved statistically significant improvements in other key efficacy measures compared to placebo after 16 weeks of treatment, including:

Lebrikizumab 250 mg every four weeks:

33.7% of lebrikizumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator¡¦s global assessment (IGA) score of 0 or 1, and a reduction of at least 2 points from baseline, compared to 15.3% with placebo (p=0.0392).

56.1% of lebrikizumab treated patients achieved a reduction of at least 75% from baseline in EASI score (EASI-75), compared to 24.3% on placebo (p=0.0021).

36.1% of lebrikizumab treated patients achieved a reduction of at least 90% from baseline in EASI score (EASI-90), compared to 11.4% on placebo (p=0.0062).

Lebrikizumab 250 mg every two weeks:

44.6% of lebrikizumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an IGA score of 0 or 1, and a reduction of at least 2 points from baseline, compared to 15.3% with placebo (p=0.0023).

60.6% of lebrikizumab treated patients achieved a reduction of at least 75% from baseline in EASI-75, compared to 24.3% on placebo (p=0.0005).

44.0% of lebrikizumab treated patients achieved a reduction of at least 90% from baseline in EASI-90, compared to 11.4% on placebo (p=0.0006).

The secondary endpoints for the 125 mg lebrikizumab dosing arm did not meet statistical significance.

The most common adverse events reported across all three lebrikizumab dosing arms were upper respiratory tract infection (7.5% vs. 5.8% for placebo), nasopharyngitis (6.6% vs. 3.8% for placebo), headache (3.1% vs. 5.8% for placebo) and injection site pain (3.1% vs. 1.9% for placebo). Rates of conjunctivitis (2.6% compared to no reports for placebo) and herpes infections (2.2% compared to no reports for placebo) were low. Overall, adverse events observed in lebrikizumab-treated patients were primarily mild to moderate in severity and infrequently led to treatment discontinuation.

¡§Based on the clinical profile observed in this study, we believe lebrikizumab has the potential to be a best-in-disease therapy for atopic dermatitis,¡¨ said Tom Wiggans, chairman and chief executive officer of Dermira. ¡§We intend to move quickly into a Phase 3 program following discussions with U.S. regulators. I want to thank the patients and investigators who participated in this trial and hope these contributions will support our ability to offer a new and differentiated treatment option to the millions of people struggling to effectively manage their atopic dermatitis.¡¨

Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.

About the Lebrikizumab Phase 2b Study

The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study was designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and to establish the dosing regimen for a potential Phase 3 program in patients with moderate-to-severe atopic dermatitis. The study enrolled 280 patients ages 18 years and older with moderate-to-severe atopic dermatitis at 57 sites in the United States. The study evaluated three different lebrikizumab treatment dosing arms compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion:

Group 1: A loading dose of 250 mg of lebrikizumab at week 0, followed by 125 mg of lebrikizumab every four weeks.

Group 2: A loading dose of 500 mg of lebrikizumab at week 0, followed by 250 mg of lebrikizumab every four weeks.

Group 3: A loading dose of 500 mg of lebrikizumab at weeks 0 and 2, followed by 250 mg of lebrikizumab every two weeks.

Group 4: Placebo at week 0 and every two weeks thereafter.

The inclusion criteria for patients enrolled in this study included chronic atopic dermatitis for at least one year, an EASI score of 16 or greater, an IGA score of 3 or 4 and a body surface area involving at least 10% at screening and baseline. Following the end of the 16-week assessment period, patients are followed for an additional 16 weeks.

About Atopic Dermatitis

Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The skin condition can have a negative impact on patients¡¦ mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.

About Lebrikizumab

Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13R£\1/IL-4R£\ heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection

www.globenewswire.com/news-release/2019/03/18/1756186/0/en/Dermira-Announces-Positive-Topline-Results-from-Phase-2b-Study-of-Lebrikizumab-in-Patients-with-Atopic-Dermatitis.html

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CONCLUSION

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more expressed than IL-4 in lesional skin and is therefore one of

the key drivers in this condition. IL-13 has a large impact on the epidermal barrier function and the local immune response............]

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News

ASLAN Pharmaceuticals prices Initial Public Offering of its American Depositary Shares

ASLAN Pharmaceuticals Limited (TPEx: 6497.TT), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced that it has priced an underwritten public offering of 6,000,000 American Depositary Shares (ADSs) at a public offering price of $7.03 per ADS.

2018/03/26·s»D½Z , °e¥óU.S. Securities and Exchange Commission (SEC) ¥Ó½ÐADSs

ASLAN Pharmaceuticals files for proposed Initial Public Offering in the U.S.

ASLAN Pharmaceuticals today announced that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of its American Depository Shares (ADSs) in the United States.

For more details, please read the English and Chinese press release.

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PRESS RELEASE

ASLAN PHARMACEUTICALS ANNOUNCES PROPOSED PUBLIC OFFERING OF AMERICAN DEPOSITARY SHARES

Singapore, 3 December 2019 ¡V ASLAN Pharmaceuticals (Nasdaq: ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, today announced that it has commenced an underwritten public offering of its American Depositary Shares (¡§ADSs¡¨) representing ordinary shares. In addition, ASLAN expects to grant the underwriter an option, exercisable at any time through and until one day before the potential closing date of this offering, to purchase up to an additional 15% of the ADSs being offered on the same terms and conditions. All ADSs to be sold in the offering will be offered by ASLAN. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

ASLAN intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund the clinical development of ASLAN004 and ASLAN003 and for general corporate purposes.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The securities described above are being offered by ASLAN pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by ASLAN with the Securities and Exchange Commission (the ¡§SEC¡¨) and that was declared effective on November 8, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC¡¦s website located at www.sec.gov. Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus and other documents we have filed with the SEC for more complete information about us and this offering. An electronic copy of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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ASLAN Pharma up 85% premarket on positive ASLAN004 data

seekingalpha.com/news/3522830-aslan-pharma-85-percent-premarket-positive-aslan004-data?mod=mw_quote_news

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www.ktgh.com.tw/Public/tbDrug/201905241612517055.pdf

P11 ¦³ DUPIXENT® (dupilumab) EASIÀø®Äµû¦ô

EASI-75 (¬Û¸û©ó°ò´Á¦Ü¤Ö§ïµ½ 75%)ªº¤H¼Æ¤ñ²v 44%-51% (¦³§½³¡¥Ö½èÃþ©T¾J(TCS)¨Ö¥ÎEASI-75 69% )

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Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ]

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2019/12/11 13.5

2019/12/12 14.9

2019/12/13 16.4

2019/12/16 18.0

2019/12/17 19.8

2019/12/18 21.8

2019/12/19 24.0

2019/12/20 26.4

2019/12/23 29.0

2019/12/24 31.9

2019/12/25 35.1

2019/12/26 38.6

2019/12/27 42.5

2019/12/30 46.8

2019/12/31 51.4

2020/1/2 56.6

2020/1/3 62.2

2020/1/6 68.5

2020/1/7 75.3

2020/1/8 82.8

2020/1/9 91.1

2020/1/10 100

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www.nejm.org/doi/full/10.1056/NEJMoa1610020

§¹¦¨¥|¶g¡]§t)¥H¤W¡A«Ü­«­n¡A½Ð°Ñ¦Òdupilumab ¤T´ÁÁ{§Éµ²ªG¡A¹Ï¤G,EASI , pruritus NRS

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ASLAN Pharmaceuticals Reports Positive Preliminary Data From Proof-of-Concept Study for ASLAN004 Targeting Atopic Dermatitis

December 02, 2019 02:07 ET | Source: ASLAN PHARMACEUTICALS LIMITED

- ASLAN004 demonstrates early signs of efficacy in the low dose cohort of multiple ascending dose study

- 3 patients completed 1 month of dosing and achieved average reduction in EASI score of 71%. Maximal efficacy expected at 6 to 8 weeks.

SINGAPORE, Dec. 02, 2019 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, today announced positive preliminary data from the lowest dose cohort of its ongoing multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate-to-severe atopic dermatitis (AD). ASLAN004 is a first-in-class fully human monoclonal antibody that binds to the IL-13 receptor £\1 subunit (IL-13R£\1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of AD, such as redness and itching of the skin.

The first patient was enrolled into the double blind study at Changi General Hospital in Singapore on 22 October 2019. As of 29 November 2019, 6 patients had been treated in the lowest dose cohort (200mg) and 3 have completed at least one month of dosing. In a review of unclean blinded data, the Eczema Area and Severity Index (EASI) scores of the 3 patients were reduced by 85%, 70% and 59% from baseline and the EASI score continued to fall at 4 weeks with maximal efficacy expected at 6 to 8 weeks. ASLAN004 was well-tolerated and, to date, there have been no serious adverse events or treatment discontinuations. Corresponding changes were seen in other measures of efficacy. The data monitoring committee (DMC) will meet in late December, after which the second dose cohort is expected to open.

The randomised, double-blind, placebo-controlled MAD study will evaluate 3 doses of ASLAN004 (between 200mg and 600mg) delivered subcutaneously and will be followed by an expansion cohort at the most efficacious dose. Each dose cohort will contain up to 6 patients on ASLAN004 and 2 patients on placebo, and the expansion cohort will contain 12 patients on ASLAN004 and 6 patients on placebo. Patients are dosed weekly for 8 weeks to determine safety and the maximal efficacy of ASLAN004. The study will recruit up to 50 moderate-to-severe atopic dermatitis patients and study completion is expected in the second half of 2020, with interim results expected in early 2020.

Dr Mark McHale, Head of R&D, ASLAN Pharmaceuticals, said: ¡§We are pleased to report encouraging preliminary data from this study of ASLAN004. Whilst the data remains early, we had not anticipated to observe such pronounced improvements in patients enrolled into the lowest dose cohort. We look forward to the second dose cohort opening following the DMC meeting in December and further interim data in early 2020.¡¨

Atopic dermatitis is the most common dermatological disease, affecting over 200 million patients worldwide, characterized by red inflamed skin and severe daytime and night-time itching, which can severely impact patients¡¦ quality of life. Up to one-third of adult atopic dermatitis patients are considered moderate to severe, for which currently available therapeutics are limited and management is challenging in the majority of cases.

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SANOFI AND REGENERON REPORT POSITIVE PROOF-OF-CONCEPT DATA FOR DUPILUMAB, AN IL-4R ALPHA ANTIBODY, IN ATOPIC DERMATITIS

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Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma

err.ersjournals.com/content/19/115/46.figures-only

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ASLAN004 ¬°¥þ¤H·½³æ®è§ÜÅé¡AÂê©w IL-13 ¨üÅé £\1 ¦¸³æ ¦ì (IL-13R£\1)¥HªýÂ_¨âºØ«P¶iµoª¢ªº²Ó­M¿E¯À IL-4 ©M IL-13 ¤§°T®§¶Ç»¼¡CIL-4 »P IL-13 ¬O¤Þµo¦p¥Ö½§µo¬õ©M·kÄo µ¥²§¦ì©Ê¥Ö½§ª¢¯gª¬ªºÃöÁä¦]¯À¡C

³o¶µ²Ä¤@´Á³æ¤@¾¯¶q»¼¼W¸ÕÅç¦b·s¥[©Y¤@³BÁ{§É¸ÕÅ礤¤ß¶i¦æ¡A¨äÅã¥Ü ASLAN004 ¥HÀR¯ßª`®g¤§µ¹ÃĤ覡¦b ©Ò¦³¾¯¶q¤U¬Ò®i²{¨}¦n¤§¦w¥þ©Ê»P­@¨ü©Ê¡A¸ÕÅ礤¥¼¦³¥X²{¤£¨}¨Æ¥ó¦Ó¾É­PªvÀø¤¤Â_ªº±¡ªpµo¥Í¡C°w¹ï¤U´å ¤¶½è©Ò¶i¦æ¤§¤ÀªRÅã¥Ü¦bµ¹ÃĪº¤@¤p®É¤º¡A¥]¬A¦b¹L±Ó©Êµoª¢¤ÏÀ³¤¤§êºt­«­n¨¤¦â¤§¤¶½è¡§ÁC»Ä¤Æ STAT6 (pSTAT6)¡¨§Y¨ü¨ì§¹¥þ§í¨î¡C¦¹§í¨î®ÄªG¥i«ùÄòªø¹F 29 ¤Ñ¡AÅã¥Ü¨C¤ëµ¹ÃĤ@¦¸¥i±æ¬°¥i¦æªºµ¹ÃĤ覡¡C

2019,3,29 ¨È·à·s»D½Z

¥¿±`¤HÅ餺¥»´N¦³¤£¦Pµ{«×ªº¹L±Óµoª¢¤ÏÀ³¡A¹L±Ó©Êµoª¢¤ÏÀ³¤¤§êºt­«­n¨¤¦â¤§¤¶½è¡§ÁC»Ä¤Æ STAT6 (pSTAT6)¡¨§Y¨ü¨ì§¹¥þ§í¨î. ¦b¥¿±`¤H¨­¤W¤w¦¨¥\¡C

Aslan004 lb·§©À©ÊÁ{§É¡C ¦b¤¤¡B­««×²§¦ì©Ê¥Ö½§ª¢±wªÌ¡]AD¡^¡A¦bÂùª¼¡A¦³¹ï·Ó²Õªºª¬ªp¤U¡A©Ò°µÁ{§É¡C 8¶g¡A8°w¡C

·PÁ Roger ¥S¡A©Ò´£¨Ñ¸ê®Æ¡A

¥D¥´¬OIL-4R©ÎIL-13R£\1¦bÀø®Ä»P¦w¥þ©Ê¤W¤´·|¦³®t²§,

¦Ó±q©³¤U3ªºCONCLUSION,¥i±À½×¹vÂIª½¥´¦bIL13ªºIL-13R£\1·|¤ñIL-4Rªº¹vÂI§ó¦³Àø®Ä! §óµL°Æ§@¥Î¡C

onlinelibrary.wiley.com/doi/pdf/10.1111/all.13954

-------Overall, this growing body of evidence suggests that AD is an IL-13-, rather than IL-4-, driven disease...

CONCLUSION

There is currently strong evidence that in AD, IL-13 is significantly

more expressed than IL-4 in lesional skin and is therefore one of

the key drivers in this condition. IL-13 has a large impact on the epidermal barrier function and the local immune response............]

¥t¥~¤w¦³¨ÌªºIL-13 °µ¹vÂIªºAD·s¬ãµoÃÄ¡A¤w¦b¤µ¦~¥|¤ë§¹¦¨²Ä¤G´ÁÁ{§É¡A¼Æ¾Ú¬Ò¥¿­±¡A¸Ô¨£1537½g¦^À³ ,

Lebrikizumab(Âê©wIL13ªºP2b¼Æ¾Ú)

med.sina.com/article_detail_103_2_62868.html

©Ò¥H¹ïIL-13 R£\1 ,1bÁ{§É§ó¦³¾÷·|¹LÃö¡A

Ãø©ÇRoger ¥S¡A¦p¦¹¦³«H¤ß¡I

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¥i®e¯Ç¼Æ­Ó¤£¦P¹vÂIªº¼Ð¹vÃĪ«¡C ¥Ø«e¦P¯Å¤¤IL-13 r £\1¹vÂI¡A¤´¦û¤W­·¡C

ROGER ¥S¡A¯uªº¼F®`¡I¨¥¤§¦³ª«¡A¥y¥y¬O­«ÂI¡C¤p§Ì¨ØªA¡C·PÁ¡C

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ROGER ¤j¡A

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«ú§Ü¾¯---[±´¯Áµo²{]¨º¥i¬O¤ë²y¬Æ¦Ü¤õ¬P¨ººØ«Ü»»»·ªº¦a¤è,¥ýµø¦Ó¤£¨£!

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¥D¥´¬OIL4©ÎIL13¦bÀø®Ä»P¦w¥þ©Ê¤W¤´·|¦³®t²§,

¦Ó±q©³¤U3ªºCONCLUSION,¥i±À½×¥D¥´¦bIL13·|§ó¦³Àø®Ä!!!

§ó¥¿¬°:

¥D¥´¬OIL-4R©ÎIL-13R£\1¦bÀø®Ä»P¦w¥þ©Ê¤W¤´·|¦³®t²§,

¦Ó±q©³¤U3ªºCONCLUSION,¥i±À½×ª½¥´¦bIL13ªºIL-13R£\1·|§ó¦³Àø®Ä!!!

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¤Ñ¥S²Ä1745ª©¦a§¹¾ãª©¶K¦b²Ä1537½g¦^À³.

ÁöµM³£¯àªýÂ_IL4»PIL13,¦ý¥D¥´¬OIL4©ÎIL13¦bÀø®Ä»P¦w¥þ©Ê¤W¤´·|¦³®t²§,

¦Ó±q©³¤U3ªºCONCLUSION,¥i±À½×¥D¥´¦bIL13·|§ó¦³Àø®Ä!!!

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´N¯à¤F¸Ñ¨È·à©xºô³o¬q»¡©úªº¨Ì¾Ú----ASLAN004¥i±æ´£¨Ñ [¾¯¶q¸û§C]»P [¥ÎÃÄÀW²v¸û§C] ¤§µ¹ÃĤ覡¡A´î¤Ö¯f±wªº­t¾á¡C¦¹¥~¡AASLAN004ªº¿ï¾Ü©Ê¸ûdupilumab¨Î¡A¦]¦¹§Ú­Ì¬Û«HASLAN004¤Þ°_ªº°Æ§@¥Î¥i±æ¸ûdupilumab»´·L¡C

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..[§Ú­Ì¹ï©óªñ´Á¤½¥¬ªº ASLAN004 ¼Æ¾Ú·P¨ì«D±`¿³¾Ä¡A§Ú­Ì¬Û«H³o¶µÃĪ«¨ã³ÆÀu©ó²{¦³ÃĪ«ªº¯S©Ê¡A¨Ã¾Ö¦³¼ç¤O¦¨¬°²§¦ì©Ê¥Ö½§ª¢¤Î¨ä¥Lµoª¢©Ê¯e¯f¤§¦P¯Å³Ì¨ÎÀøªk]----¤µ¤Ñ§ë¸êªÌ¤w»{¬°¬O¦Ñ¤ý½æ¥Ê¤F!!!

.....

3.onlinelibrary.wiley.com/doi/pdf/10.1111/all.13954

-------Overall, this growing body of evidence suggests that AD is an IL-13-, rather than IL-4-, driven disease...

CONCLUSION

There is currently strong evidence that in AD, IL-13 is significantly

more expressed than IL-4 in lesional skin and is therefore one of

the key drivers in this condition. IL-13 has a large impact on the epidermal barrier function and the local immune response............]

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dupilumab AD1BÁ{§É¸ÕÅç,¨C¶g¥´¤@°w¡A¥u°µ¥|¶g´Nµ²§ô.

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investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data/

Ãö©óIL-4R©MIL-4 / IL-13³q¸ô

¯SÀ³©Ê¥Öª¢©M¬Y¨ÇÃþ«¬ªº­ý³Ýªº¯S¼x¬O»¤¾É¯S©wÃþ«¬ªº§K¬Ì¤ÏÀ³¡A³oºØ§K¬Ì¤ÏÀ³¥ÑºÙ¬°2«¬»²§UT²Ó­M©ÎTh2²Ó­Mªº§K¬Ì²Ó­M¨È¸sÅX°Ê¡C IL-4©MIL-13¬O¤Þµo©Mºû«ùTh2§K¬ÌÀ³µª©Ò»ÝªºÃöÁä²Ó­M¦]¤l¡C IL-4©MIL-13«H¸¹§¡³q¹L¨â­Ó¤£¦PªºIL-4¨üÅé¡]I©MII«¬¡^µo¥Í¡A¥¦­Ì³£¥]§t¤@­Ó¦@¦PªºIL-4R£\¨È°ò¡C

Ãö©óDupilumab¡]SAR231893 / REGN668¡^

Dupilumab¬O°w¹ïIL-4R£\ªº§¹¥þ¤HÃþ³æ§J¶©§ÜÅé¡A³q¹L¥Ö¤Uª`®gµ¹ÃÄ¡C ³q¹LªýÂ_IL-4R¡A£\dupilumab¥i½Õ¸`IL-4©MIL-13ªº«H¸¹¶Ç¾É¡A±q¦ÓÅX°ÊTh2§K¬ÌÀ³µª¡C Dupilumab¬O¨Ï¥ÎRegeneronªº¥ý¾WVelocImmuneR§Þ³N³Ð«Øªº¡A¨Ã»PÁÉ¿Õµá¡]Sanofi¡^¦@¦P¶}µo¡C Dupilumab¥Ø«e¥¿¦b²§¦ì©Ê¥Öª¢©M­ý³Ý¤¤¶i¦æ¬ã¨s¡C

About IL-4R and the IL-4/IL-13 Pathway

Atopic dermatitis and some types of asthma are characterized by the induction of a specific type of an immune response that is driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response. Both IL-4 and IL-13 signaling occurs through two different IL-4 receptors (Type I and II), which both contain a common IL-4R alpha subunit.

About Dupilumab (SAR231893/REGN668)

Dupilumab is a fully human monoclonal antibody directed against IL-4R alpha and is administered via subcutaneous injection. By blocking IL-4R alpha dupilumab modulates signaling of both IL-4 and IL-13, drivers of a Th2 immune response. Dupilumab was created using Regeneron¡¦s pioneering VelocImmuneR technology and is being co-developed with Sanofi. Dupilumab is currently being studied in both atopic dermatitis and asthma.

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March 2, 2013 at 9:00 AM EST

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SANOFI AND REGENERON REPORT POSITIVE PROOF-OF-CONCEPT DATA FOR DUPILUMAB, AN IL-4R ALPHA ANTIBODY, IN ATOPIC DERMATITIS

¤Ú¾¤©M¯Ã¬ù¦{¶ð¨½´°¡A2013¦~3¤ë2¤é/¬ü³qªÀ/-ÁÉ¿Õµá¡]ªx¼ÚÃÒ¨é¥æ©ö©Ò¡GSAN¡A¯Ã¬ùÃÒ¥æ©Ò¡GSNY¡^©M¦A¥Í¤¸»sÃĤ½¥q¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GREGN¡^¤µ¤Ñ«Å¥¬¡A¶×Á`¤F¨â¶µ¨Ï¥Îdupilumab¡]REGN668¡^ªº1b´Á¸ÕÅ窺¼Æ¾Ú/ SAR231893¡^¡A³o¬O¤@ºØ°w¹ï¥Õ¤¶¯À4¨üÅé¡]IL-4R alpha¡^ªº°ª¿Ë©M¤O¡A¸g¥Ö¤Uµ¹ÃĪº¥þ¤HÃþ§ÜÅé¡A¤w¦b¬ü°ê¥Ö½§¯f¾Ç·|¡]AAD¡^²Ä71©¡¦~·|¤W´£¥X¦bÁÚªü±K¡C

1b´Á¬ã¨sªº¥D­n¥Øªº¬Oµû¦ôdupilumabªº¦w¥þ©Ê¡C¨ä¥L±´¯Á©Ê²×ÂI¥]¬AÃÄ¥N°Ê¤O¾Ç¡A¥Íª«¼Ð»xª«©M¥\®Ä°Ñ¼Æ¡C¥\®Ä¼Æ¾Úªí©ú¡A¨C¶g¥|¦¸¥Ö¤Uª`®gdupilumab¨C¶g150²@§J¡]mg¡^©Î300mg¶i¦æªvÀø¡A¥iÅãµÛ§ïµ½¯e¯f©M¯e¯f±o¨ì¾A·í±±¨îªº¤¤«×¦Ü­««×¯SÀ³©Ê¥Öª¢¡]AD¡^±wªÌªºÅé¼x©M¯gª¬¥~¥ÎÃĪ«¡C¨ãÅé¦Ó¨¥¡A»P¦w¼¢¾¯¬Û¤ñ¡A±q°ò½u¨ì²Ä4¶g¡A±µ¨üdupilumabªvÀøªº±wªÌªºÅéªí­±¿n¡]BSA¡^µû¤À¡A¬ã¨sªÌÁ`Åéµû¦ô¡]IGA¡^µû¤À©MÀã¯l­±¿nÄY­«©Ê«ü¼Æ¡]EASI¡^§¡¦³ÅãµÛ§ïµ½¡]p¡®¡­60 0.05 vs.©Ò¦³±¹¬I©M¾¯¶qªº¦w¼¢¾¯¡^¡C¦b300mg¾¯¶q²Õ¤¤¡A¦b²Ä8¶g¡ABSA¡AIGA©MEASIµû¤ÀªºÅãµÛ§ïµ½±o¥Hºû«ù¡]»P¦w¼¢¾¯¬Û¤ñ¡Ap¡®¡­60 0.05¡^¡C¤@¶µÅTÀ³ªÌ¤ÀªRÅã¥Ü¡A¦b²Ä4¶g¡A±µ¨ü150mg¾¯¶qªvÀøªº±wªÌ¤¤¦³54.5¢Hªº±wªÌ©M±µ¨ü300mg¾¯¶qªvÀøªº±wªÌ¤¤¦³71.4¢HªºEASI±o¤À­°§C¤F50¢H©Î§ó°ª¡A¦Ó¦w¼¢¾¯¬°18.8¢H¡]p¡®¡­60 0.05¡^¡C³Ì±`¨£ªº¤£¨}¨Æ¥ó¬O»ó«|ª¢¡]¦w¼¢¾¯¬°19.6¢H¡A¦Ó¦w¼¢¾¯¬°12.5¢H¡^©MÀYµh¡]¦w¼¢¾¯¬°11.8¢H¡A¦Ó6.3¢H¡^¡C

Á{§É¬ã¨s°Æ±Ð±Â®J¨½§J¡P¨¯´¶´Ë¡]Eric Simpson¡^³Õ¤h»¡¡G¡§¾¨ºÞ¤w¦³Àøªk¡A¤¤­««×¯SÀ³©Ê¥Öª¢±wªÌ¤¤¤´¦³«Ü¤j¤@³¡¤ÀÄ~Äò¾D¨ü¥Ö½§µoª¢©M¹x©T©Êæ±Äoªº§xÂZ¡A³oÄY­«¼vÅT¤F¥L­Ìªº¥Í¬¡½è¶q¡C¡¨ ¡A¬ü°ê«X°Ç©£¦{ªi¯SÄõ¥««X°Ç©£°·±d»P¬ì¾Ç¤j¾Ç¡A¥H¤Î¸Ó¬ã¨sªº­º®u¬ã¨s­û¡C ¡§³oºØ¨ã¦³·s¿o§@¥Î¾÷¨îªº¥Íª«Àøªkªº¦­´Áµ²ªG¹ï¨º¨ÇªvÀø³o¨Ç±wªÌ¨Ã­È±o¶i¤@¨BÁ{§É¬ã¨sªº¤H¨Ó»¡¬O¥O¤H¹ª»Rªº¡C¡¨

¡§³q¹LªýÂ_IL-4R£\¡Adupilumab¥i¥H½Õ¸`IL-4©MIL-13³~®|ªº«H¸¹¶Ç¾É¡A³o»P¹L±Ó©Ê¯e¯fªº¯f²z¥Í²z¦³Ãö¡A¡¨Âå¾Ç³Õ¤h¡A­º®uÂå¾Ç³Õ¤h³ìªv¡PD¡P´­¬ì´¶¬¥´µ»¡Regeneronªº¬ì¾Ç©x©MRegeneron¹êÅç«ÇªºÁ`µô¡C ¡§§Ú­Ì´Á«Ý¦b¤µ¦~¤U¥b¦~´£¨Ñ¤@¶µ¬°´Á12¶gªº¯SÀ³©Ê¥Öª¢ªº2a´ÁÁ{§É¸ÕÅ窺§ó¦h¼Æ¾Ú¡A¥H¤Î¦b±w¦³¯SÀ³©Ê¥Öª¢ªº±wªÌ¤¤¶}©l¨Ï¥Îdupilumab¶i¦æªº§ó¤jªº2b´ÁÁ{§É¸ÕÅç¡C¡¨

¤µ¤Ñ¦bAAD·|ijªº³Ì·sÁ{§É¸ÕÅç·|ij¤W´£¥Xªº1b´Á¸ÕÅç¥]¬A67¦ì±wªÌ¡AÀH¾÷¤À°t¤TºØ¤£¦P¾¯¶qªºdupilumab¡]75mg¡An = 8¡F 150mg¡An = 22¡F 300mg¡An = 21¡^©M¦w¼¢¾¯¡]n = 16¡^¡C 1b´Á¬ã¨sªº¥D­n¥Øªº¬Oµû¦ôdupilumabªº¦w¥þ©Ê¡C¨ä¥L²×ÂI¥]¬AÃÄ¥N°Ê¤O¾Ç¡A¥Íª«¼Ð»xª«©M¥\®Ä°Ñ¼Æ¡C¦b¬°´Á4¶gªºªvÀø´Á«á¡A¹ï¬ã¨s¤¤ªº±wªÌ¦AÀH³X4¶g¡A¦@8¶g¡C

March 2, 2013 at 9:00 AM EST

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SANOFI AND REGENERON REPORT POSITIVE PROOF-OF-CONCEPT DATA FOR DUPILUMAB, AN IL-4R ALPHA ANTIBODY, IN ATOPIC DERMATITIS

PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.

The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other exploratory endpoints included pharmacokinetic, biomarker, and efficacy parameters. The efficacy data showed that treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms of patients with moderate-to-severe atopic dermatitis (AD) whose disease was not adequately controlled with topical medications. Specifically, patients treated with dupilumab had significant improvements in body surface area (BSA) score, Investigator Global Assessment (IGA) score, and Eczema Area Severity Index (EASI) from baseline to week 4 compared to placebo (p < 0.05 vs. placebo for all measures and doses). The significant improvements in BSA, IGA, and EASI scores were maintained at week 8 in the 300mg dose group (p < 0.05 vs. placebo). A responder analysis demonstrated that at week 4, 54.5% of patients treated with the 150mg dose and 71.4% of patients treated with the 300mg dose achieved a reduction in EASI score of 50% or greater compared to 18.8% with placebo (p < 0.05). The most common adverse events (AEs) were nasopharyngitis (19.6% vs 12.5% for placebo) and headache (11.8% vs 6.3% for placebo).

Despite existing therapies, a significant proportion of patients with moderate-to-severe atopic dermatitis continue to suffer from inflamed skin and intractable itch, which significantly impacts their quality of life, said Dr. Eric Simpson, Associate Professor, Director of Clinical Studies, Oregon Health and Science University, Portland, Oregon, USA, and Principal Investigator of the study. The early phase results with this biologic therapy, which has a novel mechanism of action, are encouraging to those of us who treat these patients and warrant further clinical investigation.

Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4 and IL-13 pathway, which have been implicated in the pathophysiology of allergic disease, said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. We look forward to presenting additional data from a 12-week, Phase 2a trial in atopic dermatitis, as well as starting a larger Phase 2b trial with dupilumab in patients with atopic dermatitis, later this year.

Presented today in a late-breaking clinical trials session at the AAD meeting, the Phase 1b trials included 67 patients randomized to three different doses of dupilumab (75mg, n=8; 150mg, n=22; 300mg, n=21) and placebo (n=16). The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab. Other endpoints included pharmacokinetic, biomarker, and efficacy parameters. Following the 4-week treatment period, patients in the studies were followed for an additional 4 weeks for a total of 8 weeks.

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INDICATIONS

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2019-financial-and-operating

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Dupixent Approval History

FDA Approved: Yes (First approved March 28, 2017)

Brand name: Dupixent

Generic name: dupilumab

Dosage form: Injection

Company: Sanofi and Regeneron Pharmaceuticals, Inc.

Treatment for: Atopic Dermatitis, Asthma

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Development History and FDA Approval Process for Dupixent

Date

Article

Jun 26, 2019 Approval FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis

Mar 11, 2019 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents

Oct 19, 2018 Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma

Mar 28, 2017 Approval FDA Approves Dupixent (dupilumab) for Eczema

Mar 4, 2017 Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent (dupilumab) in Moderate-to-Severe Atopic Dermatitis

Oct 1, 2016 Sanofi and Regeneron Announce Positive Dupixent (dupilumab) Phase 3 Atopic Dermatitis Data Published in The New England Journal of Medicine

Sep 26, 2016 Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA

Jun 6, 2016 Sanofi and Regeneron Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients

Apr 1, 2016 Sanofi and Regeneron Announce Positive Dupilumab Topline Results From Two Phase 3 Trials in Inadequately Controlled Moderate-To-Severe Atopic Dermatitis Patients

Feb 2, 2016 Sanofi and Regeneron Announce Publication of Positive Phase 2 Dupilumab Data

May 18, 2015 Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma

Nov 20, 2014 Sanofi And Regeneron Announce That Dupilumab Has Received FDA Breakthrough Therapy Designation In Atopic Dermatitis

Nov 11, 2014 Sanofi And Regeneron Announce Positive Results From Phase 2b Study of Dupilumab

Oct 20, 2014 Sanofi And Regeneron Announce Start Of Phase 3 Study Of Dupilumab in Patients With Atopic Dermatitis

Sep 30, 2014 Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps

Jul 9, 2014 Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab for Atopic Dermatitis

May 21, 2013 Sanofi and Regeneron Announce Publication of Positive Phase 2a Results of Dupilumab in Asthma

Mar 4, 2013 Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis

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