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RPT193 is designed to selectively inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4, a receptor highly expressed on Th2 cells.
RAPT Therapeutics Announces Proposed Public Offering of Common Stock RAPT Therapeutics, Inc. Tue, June 15, 2021, 4:01 AM
RAPT +115.51% SOUTH SAN FRANCISCO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced that it has commenced an underwritten public offering of $125 million of its common stock. In addition, RAPT expects the underwriters to be granted a 30-day option to purchase up to an additional $18.75 million of its common stock on the same terms and conditions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.
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RAPT Therapeutics Reports Positive Topline Results from Phase 1b Trial of RPT193 Monotherapy in Atopic Dermatitis
RAPT +115.51% RAPT Therapeutics, Inc. Mon, June 14, 2021, 8:00 PM
RAPT +115.51% • Improvements demonstrated in all key exploratory efficacy endpoints - percent change in EASI, EASI-50, vIGA and pruritis NRS - at four weeks following once-daily oral treatment with RPT193 • Further improvement in percent change in EASI, EASI-50 and vIGA observed with RPT193 two weeks after end of treatment • RPT193 was well tolerated with no serious adverse events • RAPT plans to advance RPT193 to Phase 2b clinical trial in atopic dermatitis • Management to host webcast conference call today at 8:30 a.m. ET
SOUTH SAN FRANCISCO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced positive topline results from its randomized placebo-controlled Phase 1b clinical trial of RPT193 as monotherapy in 31 patients with moderate-to-severe atopic dermatitis (AD). After four weeks of treatment, patients with moderate-to-severe AD who received RPT193 showed a 36.3% improvement from baseline in the Eczema Area and Severity Index (EASI) score, a standard measure of disease severity, compared to 17.0% in the placebo group. Notably, in the two-week period following the end of treatment, the RPT193 group showed continued improvement and further separation from placebo with a 53.2% improvement in EASI at the six-week time point compared to 9.6% in the placebo group. This continued improvement may be related to RPT193¡¦s mechanism of action, which is upstream of other agents targeting cytokines or signaling pathways.
¡§These data strongly support the potential of RPT193 as a safe, once-daily, oral treatment for patients with atopic dermatitis which would be an attractive therapeutic alternative ahead of injectable drugs,¡¨ said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. ¡§We look forward to advancing RPT193 to a Phase 2b trial in atopic dermatitis and a Phase 2a trial in asthma.¡¨
Emma Guttman-Yassky, M.D., Ph.D., the Waldman Professor of Dermatology and System Chair Department of Dermatology at the Icahn School of Medicine at Mount Sinai, and member of RAPT¡¦s Scientific Advisory Board, added, ¡§I am very excited about these results as they not only demonstrate clinically meaningful improvement after just four weeks of treatment, but also further improvement for two weeks after completion of treatment. This may suggest that this novel mechanism of action targeting CCR4 on Th2 cells could have prolonged, disease-modifying effects, which could differentiate it from other agents. Along with being an oral drug that seems to have promising clinical activity and a well-tolerated safety profile, RPT193 could fill a high unmet medical need for AD patients.¡¨
Key Findings from the Phase 1b Study In the Phase 1b study, 21 patients with moderate-to-severe atopic dermatitis were treated with 400 mg of RPT193, administered orally once a day for four weeks, while 10 patients received placebo. The RPT193 group showed clear improvement in key efficacy measures compared to placebo at the end of the four-week treatment period, including improvement in the Eczema Area and Severity Index (EASI) score, validated Investigator Global Assessment (vIGA) and pruritis Numerical Rating Scale (NRS):
Patients treated with RPT193 achieved a 36.3% improvement in EASI score from baseline compared with a 17.0% improvement in patients in the placebo group
42.9% of patients treated with RPT193 achieved a 50% improvement in EASI score (EASI-50) compared with 10.0% in the placebo group
4.8% of patients treated with RPT193 achieved a vIGA score of 0/1 and at least a two-point improvement over baseline compared with 0.0% in the placebo group; and
45.0% of patients treated with RPT193 achieved at least a four-point reduction in the pruritus NRS score, compared with 22.2% in the placebo group
Patients were also evaluated for exploratory endpoints at six weeks (two weeks after the end of treatment). At six weeks, the patients treated with RPT193 showed further improvement in EASI score and vIGA:
Patients treated with RPT193 achieved a 53.2% improvement in EASI score from baseline compared with a 9.6% improvement in patients in the placebo group
61.9% of patients treated with RPT193 achieved EASI-50 compared with 20.0% in the placebo group; and
14.3% of patients treated with RPT193 achieved a vIGA score of 0/1 and at least a two-point improvement over baseline compared with 0.0% in the placebo group
Based on exploratory statistical analyses, the difference between RPT193 and placebo on the percent change in EASI score and EASI-50 was statistically significant at Day 43 (p < 0.05). No other endpoints or timepoints achieved statistical significance.
RPT193 was well tolerated in the Phase 1b study. No serious adverse events were reported, and all adverse events reported were mild or moderate in intensity. The overall safety profile of RPT193 to date, including the Phase 1b study and the previously reported blinded safety data from our Phase 1a study in healthy volunteers, suggests RPT193 is a well-tolerated oral drug that would not require any laboratory safety monitoring.
In addition to the topline data reported today, RAPT intends to report additional data and analyses in a future publication or at an upcoming medical conference.
Based on the efficacy and safety data observed in the Phase 1b study, RAPT plans to initiate a dose-ranging Phase 2b study in patients with moderate-to-severe AD and is also planning a Phase 2a study in asthma.
About the Phase 1a/1b Study of RPT193 The Phase 1b study reported today is part of RAPT¡¦s first-in-human Phase 1a/1b trial of RPT193. The Phase 1b portion of the trial is a randomized, double-blind, placebo-controlled study examining RPT193 as monotherapy in patients with moderate-to-severe AD. The study was conducted at multiple sites in the United States and enrolled 31 patients with moderate-to-severe AD who had an inadequate response to, or were intolerant of, topical corticosteroids. The primary endpoint of the Phase 1b study is safety. Secondary and exploratory endpoints include pharmacokinetics, biomarkers and clinical efficacy as evaluated by multiple measurements, including percent change in the Eczema Area and Severity Index (EASI) score, the validated Investigator Global Assessment (vIGA) and pruritis Numerical Rating Scale (NRS). The Phase 1b trial was not powered to achieve statistical significance for any particular endpoint.
The Phase 1a portion of the Phase 1a/1b trial was a standard single and multiple dose-escalation study in healthy volunteers. The data from the Phase 1a study demonstrated pharmacokinetics and pharmacodynamics that support once-daily oral dosing with RPT193, and blinded safety data supported initiation of the Phase 1b portion of the trial.
Conference call and webcast details RAPT will host a conference call accompanied by a slide presentation today, Monday, June 14, 2021, at 8:30 a.m. ET. The live webcast and audio archive of the presentation is available on the RAPT Therapeutics website at investors.rapt.com/events-and-presentations. The call can be accessed by dialing (833) 672-0665 (domestic) or (929) 517-0344 (international) and referring to conference ID 4696044. The webcast replay will be available for 30 days.
About RPT193 RPT193 is a small molecule oral therapy in development for the treatment of atopic dermatitis and other inflammatory diseases. RPT193 is designed to selectively inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4, a receptor highly expressed on Th2 cells. Preliminary data suggest that RPT193 also has the potential to modulate Th2 cell function by lowering the secretion of Th2 cytokines upon stimulation. In allergic inflammatory diseases such as AD, chemokines recruit Th2 cells via CCR4 into inflamed tissues, where the Th2 cells secrete proteins known to drive the inflammatory response. The role of Th2 cells has been clinically validated by injectable biologics targeting this pathway. Patients with atopic dermatitis express higher levels of CCR4 ligands compared with healthy humans; these ligands also correlate with the severity of disease. RAPT believes that by inhibiting CCR4, RPT193 has the potential to bring therapeutic benefit to patients across a broad spectrum of inflammatory diseases, including atopic dermatitis, asthma, chronic urticaria, allergic rhinitis, chronic rhinosinusitis and eosinophilic esophagitis. |
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MRNA-1273 SPONSOR BRIEFING DOCUMENT VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING DATE: 17 DECEMBER 2020 AVAILABLE FOR PUBLIC RELEASE
Table 10: Serum IgG ELISA Endpoint Titer Geometric Mean Results With 95% Confidence Intervals by Time Point and Vaccination Group in Study 101 ¡V Spike Stabilized Antigen (S-2P) ¡V Age 18 to 55 Years
GMT Day 57 Post-Vaccination 1 (28 Days Post-Vaccination 2) --------- 299751----25£gg mRNA-1273 562064 ----50£gg mRNA-1273 782719 -----100£gg mRNA-1273 1255376-----250£gg mRNA-1273
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Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis clinicaltrials.gov/ct2/show/NCT03703102?term=KHK4083+ad&draw=2&rank=1
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¥»¦¸±ÂÅv Under the deal, Kyowa Kirin will receive $400 million upfront and potentially as much as $850 million more if certain goals are met. Amgen plans to take charge of development, manufacturing and commercialization activities, except in Japan. Kyowa Kirin will hold co-promotion rights in the U.S. and can opt in to co-promote the product in certain other markets.
®Ú¾Ú¨óij¡A¨ó©MÄQÅï(Kyowa Kinin)±NÀò±o 4 »õ¬ü¤¸ªº¹w¥I´Ú¡A¦pªG¹ê²{¬Y¨Ç¥Ø¼Ð¡A«h¥i¯à¦hÀò±o 8.5 »õ¬ü¤¸¡C ¦w¶ip¹ºt³d°£¤é¥»¥H¥~ªº¶}µo¡B»s³y©M°Ó·~¤Æ¬¡°Ê¡C Kyowa Kirin ±N¦b¬ü°ê¾Ö¦³¦@¦P±À¼sÅv¡A¨Ã¥B¥i¥H¿ï¾Ü¦b¬Y¨Ç¨ä¥L¥«³õ¦@¦P±À¼s¸Ó²£«~¡C
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Kyowa Kirin Announces Positive Phase 2 Results for KHK4083 in Patients with Moderate to Severe Atopic Dermatitis Atopic dermatitis is a chronic, pruritic, inflammatory dermatosis that is believed to affect an estimated number of 26M patients in North America, EU, and Japan1 KHK4083, an anti-OX40 fully human monoclonal antibody discovered by Kyowa Kirin, shows a combination of antibody dependent cellular cytotoxicity (ADCC) and antagonist activity against OX40 Kyowa Kirin plans to present the detailed results of the Phase 2 study through future academic conferences or publications February 18, 2021 06:43 AM Eastern Standard Time
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¥H¤U«ÂI´N¬O³o¤@¦æ An expansion cohort (Cohort 4) of approximately 27 patients is planned and will be randomized in a 2:1 ratio to receive ASLAN004 (n=18) or matching placebo (n=9). The rationale for this is to provide greater assurance about the safety and tolerability of the selected dose level, and to provide preliminary estimates of the PD and clinical effects at this dose, prior to further dose and schedule finding work in Phase 2 studies.
Study Description Brief Summary: A Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment. Detailed Description: The study is designed as a MAD escalation in up to 3 cohorts of patients, followed by a cohort expansion to further confirm the safety and tolerability of the selected dose, prior to further investigation in Phase 2 studies. The cohort expansion will also support the assessment of the trial¡¦s secondary efficacy objectives. Approximately 50 patients are planned to be enrolled across the entire study. Approximately 24 patients are planned to be enrolled in the initial MAD escalation, with a maximum of 3 ascending dose levels (low, medium and high) of ASLAN004 (Cohorts 1-3). In all dose cohorts, 8 patients will be randomized in a 3:1 ratio to receive ASLAN004 (at specified cohort dose, n=6) or matching placebo (n=2). Additional cohorts may be optional depending on the data from the preceding cohort.
An expansion cohort (Cohort 4) of approximately 27 patients is planned and will be randomized in a 2:1 ratio to receive ASLAN004 (n=18) or matching placebo (n=9). The rationale for this is to provide greater assurance about the safety and tolerability of the selected dose level, and to provide preliminary estimates of the PD and clinical effects at this dose, prior to further dose and schedule finding work in Phase 2 studies.
A total of 8 subcutaneous injections of ASLAN004 or matching placebo will be administered according to a weekly schedule of injection from Day 1 (baseline visit) to Day 50 (Week 7) of the study. Patients will be closely monitored and observed for a period of 30 minutes after each injection of study drug (all visits). The clinical assessments and blood sampling for safety laboratory tests, PK analysis, ADA assays, and biomarkers will be performed at each visit as noted in the Schedule of Assessments. The treatment period will end at the last day of Week 8 (ie., Day 56) after which patients will be followed every week for 12 weeks for safety, PK parameters, ADA, and PD marker assessments. In the event that patients develop adverse events (AEs)/serious AEs (SAEs) which are determined as definitely related, probably related, or possibly related to ADA, and/or patients have a positive ADA result, additional unscheduled sampling of ADA may be performed during the study or after Day 141, as deemed clinically necessary. The exact timepoints for ADA sampling after Day 141 will be discussed between the Investigator and Sponsor for each case. |
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RTW INVESTMENTS, LP 3,250,000 VIVO CAPITAL, LLC 2,840,909 ORBIMED ADVISORS LLC 2,520,000 LOGOS GLOBAL MANAGEMENT LP 2,300,000 MANGROVE PARTNERS 2,178,063 LUMINUS MANAGEMENT LLC 1,753,800 TEMASEK HOLDINGS (PRIVATE) LTD 1,678,075 SIO CAPITAL MANAGEMENT, LLC 1,448,508 ASYMMETRY CAPITAL MANAGEMENT, L.P. 1,352,57 MILLENNIUM MANAGEMENT LLC 1,246,275 IKARIAN CAPITAL, LLC 1,224,516
SABBY MANAGEMENT, LLC 817,165 DAFNA CAPITAL MANAGEMENT LLC 677,500 CITADEL ADVISORS LLC 652,511 PLATINUM INVESTMENT MANAGEMENT LTD 514,984 KNOTT DAVID M 437,412 MONASHEE INVESTMENT MANAGEMENT LLC420,000 GOLDMAN SACHS GROUP INC 407,464 PARKMAN HEALTHCARE PARTNERS LLC 325,000 RENAISSANCE TECHNOLOGIES LLC 258,467 AFFINITY ASSET ADVISORS, LLC 200,000 MYDA ADVISORS LLC 200,000 CAAS CAPITAL MANAGEMENT LP 150,000 BOOTHBAY FUND MANAGEMENT, LLC 130,920 BARCLAYS PLC 128,586
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www.smarteranalyst.com/new-blurbs/aslan-pharmaceuticals-asln-gets-a-buy-rating-from-h-c-wainwright-2/?mod=mw_quote_news ¨é°Ó H.C.Wainwrihjt «¥ÓASLN ¥Ø¼Ð»ù8¬ü¤¸ Aslan Pharmaceuticals (ASLN) Gets a Buy Rating from H.C. Wainwright Austin Angelo- May 12, 2021, 6:17 AM EDT SHARE ON: In a report released today, Yi Chen from H.C. Wainwright reiterated a Buy rating on Aslan Pharmaceuticals (ASLN), with a price target of $8.00. The company¡¦s shares closed last Tuesday at $2.78.
According to TipRanks.com, Chen is a top 100 analyst with an average return of 58.8% and a 49.2% success rate. Chen covers the Healthcare sector, focusing on stocks such as Ortho Clinical Diagnostics Holdings, Interpace Diagnostics Group, and HTG Molecular Diagnostics.
Currently, the analyst consensus on Aslan Pharmaceuticals is a Moderate Buy with an average price target of $8.00, a 200.8% upside from current levels. In a report released yesterday, Piper Sandler also maintained a Buy rating on the stock with a $8.00 price target. |
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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: ¡§We have continued to make solid progress in 2021 and we are on track to complete the expansion cohort in our multiple ascending dose trial for ASLAN004 with an additional 27 patients expected to be enrolled by mid-2021 followed by the announcement of topline data expected in the third quarter of 2021.
ASLAN Pharmaceuticalsº®u°õ¦æ©xCarl Firth³Õ¤h»¡¡G¡§§Ú̦b2021¦~Ä~Äò¨ú±oèB¶i®i¡A§Ú̦³±æ¦bASLAN004ªº¦h¾¯¶q»¼¼W¸ÕÅ礤§¹¦¨ÂX®i¶¤¦C©Û¶Ò¡A¹wpÁÙ±N¦³27¦W±wªÌ¤J²Õ ¨ì2021¦~¤¤¦¯¡AÀH«á¤½§G¤F¹w´Á¦b2021¦~²Ä¤T©u«×µo¥¬ªºªì¨B¼Æ¾Ú¡C
We are excited to expand our senior management team with two highly experienced executives, Dr Karen Veverka, who will be leading our clinical development program, and Joseph Suttner to lead clinical operations. In addition, we are preparing for our Phase 2b trial for ASLAN004, which we expect to initiate in the second half of 2021. Our robust financial position provides the resources to fund development activities and achieve additional value creating milestones for shareholders.¡¨
§ÚÌ«Ü°ª¿³¯à»P¨â¦ì¸gÅçÂ×´Iªº°ªºÞ¤@°_ÂX¤j§Ú̪º°ª¯ÅºÞ²z¹Î¶¤¡A¥ḺN»â¾É§Ú̪ºÁ{§É¶}µop¹ºªºKaren Veverka³Õ¤h©M¬ù·æ¤Ò¡PĬ¯S¯Ç¡]Joseph Suttner¡^»â¾ÉÁ{§É¹BÀç¡C ¦¹¥~¡A§ÚÌ¥¿¦b¬°ASLAN004ªº2b´Á¸ÕÅç°µ·Ç³Æ¡A§Ú̧Ʊæ¦b2021¦~¤U¥b¦~¶}©l¸ÕÅç¡C§ÚÌ𷪺°]°Èª¬ªp¬°¶}µo¬¡°Ê´£¨Ñ¸êª÷¡A¨Ã¬°ªÑªF³Ð³y¤FÃB¥~ªº»ùÈ¡A¹ê²{¤F¨½µ{¸O¡C¡¨
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1. Appointed Dr Karen Veverka as Vice President, Medical to lead ASLAN¡¦s clinical medical development program for new products, including Phase 2 and 3 trials. Dr Veverka brings more than 20 years of experience in the pharmaceutical industry, as well as significant preclinical and clinical research and development (R&D) experience in immunology and dermatology. Prior to joining ASLAN, Dr Veverka was Senior Medical Director and Medical Head for the Innovative Portfolio at LEO Pharma, a leader in global dermatology. At LEO she led the development of brand medical strategy and execution of medical affairs activities for products in the AD and psoriasis therapeutic areas, including tralokinumab. Dr Veverka has also held leadership roles at Novartis and GTx. Dr Veverka earned her PhD in Pharmacology at The Mayo Clinic Graduate School of Biomedical Sciences and completed a postdoctoral research fellowship at St Jude Children¡¦s Research Hospital.
¥ô©RKaren Veverka³Õ¤h¬°Âå¾Ç³¡°ÆÁ`µô¡A »â¾ÉASLAN°w¹ï·s²£«~ªºÁ{§ÉÂå¾Ç¶}µop¹º¡A¥]¬A2´Á©M3´Á¸ÕÅç¡C Veverka³Õ¤h¦b»sÃĦæ·~¾Ö¦³20¦h¦~ªº¸gÅç¡A¨Ã¦b§K¬Ì¾Ç©M¥Ö½§¯f¾Ç¤è±¨ã¦³«nªºÁ{§É«e©MÁ{§É¬ã¨s»P¶}µo¡]R¡®D¡^¸gÅç¡C ¥[¤JASLAN¤§«e¡AVeverka³Õ¤h´¿¬O¥þ²y¥Ö½§¯f¾Ç»â¾ÉªÌLEO Pharmaªº°ª¯ÅÂå¾ÇÁ`ºÊ©M³Ð·s²£«~²Õ¦XªºÂå¾Çt³d¤H¡C ¦bLEO¡A¦o»â¾É«~µPÂåÀø¾Ô²¤ªº»s©w©MÂåÀø¨Æ°Èªº°õ¦æ ****(LEO ªº Tralokinumab¹w´Á¤µ¦~Q3¨ú±o Ä~dupilumab ªº²Ä¤G±i³æ®è§ÜÅéªvÀø¤¤-««× AD ¬ü°êÃĵý) AD©M¤û¥ÖÅ~ªvÀø»â°ì²£«~ªº¬¡°Ê¡A¥]¬Atralokinumab¡C Veverka³Õ¤hÁÙ´¿¦b¿ÕµØ©MGTx¾á¥ô»â¾É¾°È¡C Veverka³Õ¤h¦b¬ü°ê±ö¶ø¶E©Ò¥Íª«Âå¾Ç¬ì¾Ç¬ã¨s©ÒÀò±oÃIJz¾Ç³Õ¤h¾Ç¦ì¡A¨Ã¦b¸t¸Ê¼w¨àµ£¬ã¨sÂå°|§¹¦¨¤F³Õ¤h«á¬ã¨s¼ú¾Çª÷¡C
2. Appointed Joseph Suttner as Vice President, Clinical Operations. Mr Suttner brings more than 20 years in clinical operations and R&D, including more than 8 years in dermatology. Mr Suttner has successfully led clinical operations teams at Dermira, PellePharm and several other biotechnology companies through Phase 2b trials in AD, Gorlin syndrome, and actinic keratosis, among other conditions ¥ô©R¬ù·æ¤Ò¡PÂįS¯Ç¬°Á{§É¹BÀç°ÆÁ`µô¡C Suttner¥ý¥Í¾Ö¦³20¦h¦~ªºÁ{§É¹BÀç©M¬ãµo¸gÅç¡A¨ä¤¤¥]¬A8¦h¦~ªº¥Ö½§¯f¾Ç¸gÅç¡C Suttner¥ý¥Í¦¨¥\¦a»â¾É¤FDermira¡APellePharm©M¨ä¥L´X®a¥Íª«§Þ³N¤½¥qªºÁ{§É¹BÀç¹Î¶¤³q¹LAD¡AGorlinºî¦X¼x©M¥ú¤Æ©Ê¨¤¤Æ¯fµ¥¯e¯fªº2b´ÁÁ{§É¸ÕÅç
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ASLAN PHARMACEUTICALS TO PRESENT DATA ON ASLAN004 AT SOCIETY FOR INVESTIGATIVE DERMATOLOGY ASLAN»sÃĤ½¥q±N¦bASLAN004¤W´£¨Ñ¼Æ¾Ú¥H¨Ñ½Õ¬d¥Ö½§¬ì
ASLAN will give a poster presentation of new data from its Single Ascending Dose (SAD) study of ASLAN004, during the virtual event on 6 May, 2021 Singapore, 5 May 2021 ¡V ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that an abstract on ASLAN004 has been accepted for poster presentation at the upcoming 2021 Society for Investigative Dermatology (SID) virtual meeting between 3-8 May, 2021. The data is available to view during the Pharmacology and Drug Development segment on 6 May, 2.30pm to 4pm EST, and will be published in the fall edition of the Journal of Investigative Dermatology. The late-breaking abstract accepted for poster presentation (Abstract #LB793), titled ¡§A phase 1, open-label, single ascending dose study in healthy subjects of the safety, tolerability and pharmacokinetics of ASLAN004, a novel IgG anti-IL-13 receptor alpha 1 Inhibitor¡¨, will be presented by Dr Lawrence Soon-U Lee, first author of the abstract. Other authors of the SAD abstract include Dr Hartina Hajireen from the Clinical Trials & Research Unit, Changi General Hospital, and Dr Alison Ward, from ASLAN Pharmaceuticals.
ASLAN±N¦b¨ä³æ¦¸¾¯¶q¡]SAD¡^¬ã¨s¤¤¹ï·s¼Æ¾Ú¶i¦æ®ü³ø®i¥Ü¡C ASLAN004¡A¦b2021¦~5¤ë6¤éªºµêÀÀ¬¡°Ê¤¤ 2021¦~5¤ë5¤é¡A·s¥[©Y¡V ASLAN Pharmaceuticals¡]NASDAQ¡GASLN¡^¡A±Mª`©óÁ{§É¶¥¬q§K¬Ì¾Ç ¥Íª«»sÃĤ½¥q¤µ¤Ñ«Å¥¬¶}µo³Ð·sÀøªk¥H§ïÅܱwªÌªº¥Í¬¡ ¦b§Y±N¨ì¨Óªº2021¦~¾Ç·|¤W¡AÃö©óASLAN004ªººKn¤w³Q±µ¨ü¥Î©ó®ü³ø®i¥Ü¡C 2021¦~5¤ë3¤é¦Ü8¤é¤§¶¡¶i¦æªº¬ã¨s©Ê¥Ö½§¯f¡]SID¡^µêÀÀ·|ij¡C ÃIJz¾Ç©MÃĪ«¶}µo³¡¤À±N©ó5¤ë6¤é¡A¬ü°êªF³¡¼Ð·Ç®É¶¡2.30pm¦Ü4pm¡C ¥Ö½§¯f¾Ç¬ã¨sÂø»x¡C ³Ì·sªººKn³Q±µ¨ü§@®ü³ø®i¥Ü¡]ºKn¡LB793¡^¡A¼ÐÃD¬°¡§ A´Á1¡A¶}©ñ¼ÐÅÒ¡A³æ¤@ ¦b°·±d¨ü¸ÕªÌ¤¤¹ï·s«¬IgG ASLAN004ªº¦w¥þ©Ê¡A@¨ü©Ê©MÃÄ¥N°Ê¤O¾Ç¶i¦æ¾¯¶q»¼¼W¬ã¨s ºKnªº²Ä¤@§@ªÌLawrence Soon-U Lee³Õ¤h±N¤¶²Ð§ÜIL-13¨üÅé£\1§í»s¾¯¡¨¡C SADºKnªº¨ä¥L§@ªÌ¥]¬A¼Ì©yÁ{§É¸ÕÅç»P¬ã¨s³¡ªùªºHartina Hajireen³Õ¤h Á`Âå°|©MASLAN PharmaceuticalsªºAlison Ward³Õ¤h¡C ¤@ºØ
ASLAN004 is a novel, fully human monoclonal antibody that targets the IL-13 receptor £\1 subunit, or IL-13R£\1, with potential to be a first-in-class therapy for atopic dermatitis and asthma. During the SID meeting, new data will be presented from the Single Ascending Dose (SAD) healthy volunteer study, completed in 2019, that demonstrated ASLAN004¡¦s favourable tolerability profile as an IL-13R£\1 inhibitor and as a differentiated treatment method for atopic dermatitis patients. The SAD data readout supported ASLAN¡¦s decision to initiate the ongoing, phase 1b Multiple Ascending Dose (MAD) study of ASLAN004. The poster will be available to view online in the news and publications section of the ASLAN website at 2:30pm ET, 2:30am SGT. aslanpharma.com/news/ All presentations from the event will be available to view on demand until 31 May. More information on the presentations available during the event can be found here: www.sidannualmeeting.org/information/meeting-program-attendee-user-guide/.
ASLAN004¬O¤@ºØ·s«¬ªº¡A§¹¥þ¤H·½ªº³æ§J¶©§ÜÅé¡A¥i¹v¦VIL-13¨üÅé£\1¨È°ò©ÎIL-13R£\1¡A¨ã¦³ ¦³¼ç¤O¦¨¬°¯SÀ³©Ê¥Öª¢©Mý³Ýªº¤@¬yÀøªk¡C¦bSID·|ij´Á¶¡¡A·s¼Æ¾Ú±N ¥Ñ³æ¦¸¾¯¶q¡]SAD¡^°·±d§ÓÄ@ªÌ¬ã¨s¡]©ó2019¦~§¹¦¨¡^´£¨Ñ¡AÃÒ©ú¤F ASLAN004§@¬°IL-13R£\1§í»s¾¯©M§@¬°®t²§ªvÀø¤èªkªº¨}¦n@¨ü©Ê ¯SÀ³©Ê¥Öª¢±wªÌ¡C SAD¼Æ¾ÚŪ¨ú¤ä«ùASLAN¨M©w±Ò°Ê¥¿¦b¶i¦æªº1b¶¥¬q ASLAN004ªº¦h«¤W¤É¾¯¶q¡]MAD¡^¬ã¨s¡C ¸Ó®ü³ø±N¦b¬ü°êªF³¡®É¶¡¤U¤È2:30¦bASLANºô¯¸ªº·s»D©M¥Xª©ª«³¡¤À´£¨Ñ¡A¥H¦b½uÆ[¬Ý¡A SGT¡G2¡G30am¡C aslanpharma.com/news/ ¸Ó¬¡°Êªº©Ò¦³ºtÁ¿±N¦b5¤ë31¤é¤§«e«ö»Ý´£¨Ñ¡C¦³Ãöªº§ó¦h«H®§ ¬¡°Ê´Á¶¡¥i¥Îªººt¥Ü¤å½Z¥i¥H¦b¥H¤U¦ì¸m§ä¨ì¡G www.sidannualmeeting.org/information/meeting-program-attendee-user-guide/¡C
About ASLAN Pharmaceuticals About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (Nasdaq:ASLN) is a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients. Led by a senior management team with extensive experience in global development and commercialisation, ASLAN has a clinical portfolio comprised of a first-in-class monoclonal therapy, ASLAN004, that is being developed in atopic dermatitis and other immunology indications, and ASLAN003, which it plans to develop for autoimmune disease. For additional information please visit www.aslanpharma.com About ASLAN004 ASLAN004 is a potential first-in-class human monoclonal antibody that binds to the IL-13 receptor £\1 subunit (IL13R£\1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of atopic dermatitis (AD), such as redness and itching of the skin. AD is a chronic, inflammatory skin condition which severely impacts quality of life for millions of children and adults globally. ASLAN004 is the only IL13R£\1 receptor in clinical development for the treatment of AD
Ãö©óASLAN»sÃÄ Ãö©óASLAN»sÃĤ½¥qASLAN»sÃĤ½¥q¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GASLN¡^¬O±Mª`©óÁ{§É¶¥¬q§K¬Ì¾Çªº ¥Íª«»sÃĤ½¥q¥¿¦b¶}µo³Ð·sÀøªk¡A¥H§ïÅܱwªÌªº¥Í¬¡¡C¥Ñ°ª¯Å»â¾É ºÞ²z¹Î¶¤¦b¥þ²y¶}µo©M°Ó·~¤Æ¤è±¾Ö¦³Â×´Iªº¸gÅç¡AASLAN¨ã¦³Á{§É¸gÅç ¥]¬A¦b²§¦ì©Ê¥Öª¢¤¤¶}µoªº¤@¬yªº³æ§J¶©ÀøªkASLAN004²Õ¦¨ªº²£«~²Õ¦X ©M¨ä¥L§K¬Ì¾Ç¾AÀ³¯g¡A¥H¤Îp¹º¶}¾v¥Î©ó¦Û¨§K¬Ì©Ê¯e¯fªºASLAN003¡CÃB¥~ªº «H®§¡A½Ð³X°Ýwww.aslanpharma.com Ãö©óASLAN004 ASLAN004¬O»PIL-13¨üÅé£\1¨È°òµ²¦Xªº¼ç¦bªº¤@¬y¤HÃþ³æ§J¶©§ÜÅé ¡]IL13R£\1¡^¡AªýÂ_¨âºØ«Pª¢²ÓM¦]¤lIL-4©MIL-13ªº«H¸¹¶Ç¾É¡A³o¨âºØ¦]¤l¬OIJµoªºÃöÁä ¯SÀ³©Ê¥Öª¢¡]AD¡^ªº¯gª¬¡A¨Ò¦p¥Ö½§µo¬õ©Mæ±Äo¡C AD¬O¤@ºØºC©Êª¢¯g©Ê¥Ö½§ ³oºØª¬ªpÄY«¼vÅT¤F¥þ²y¼Æ¦Ê¸U¨àµ£©M¦¨¦~¤Hªº¥Í¬¡½è¶q¡C ASLAN004¬O°ß¤@ªº IL13R£\1¨üÅé¦bADªvÀø¤¤ªºÁ{§É¶}µo
Forward looking statements This release and the accompanying financial information, if any, contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the Company). These forward-looking statements may include, but are not limited to, statements regarding the Company¡¦s business strategy and clinical development plans; the Company¡¦s plans to develop and commercialise ASLAN004 and ASLAN003; the safety and efficacy of ASLAN004 and ASLAN003; the Company¡¦s plans and expected timing with respect to clinical trials and clinical trial results for ASLAN004 and ASLAN003; the Company¡¦s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for ASLAN004 and ASLAN003; the potential for ASLAN004 as a novel, first-in class antibody targeting IL-13R with a differentiated efficacy and safety profile in atopic dermatitis; and the Company¡¦s belief that its cash and cash equivalents will be sufficient to fund operations into 2023. The Company¡¦s estimates, projections and other forward-looking statements are based on management¡¦s current assumptions and expectations of future events and trends, which affect or may affect the Company¡¦s business, strategy, operations or financial performance, and inherently involve significant known and unknown risks and uncertainties
«e¤©ÊÁn©ú ¥»·s»D½Z©MÀHªþªº°]°È«H®§¡]¦p¦³¡^¥]§t«e¤©ÊÁn©ú¡C³o¨Ç Án©ú°ò©óASLAN Pharmaceuticals LimitedºÞ²z¼hªº·í«e«H©À©M´Á±æ ©M/©Î¨äÃöÁp¤½¥q¡]¥H¤U²ºÙ¡§¤½¥q¡¨¡^¡C³o¨Ç«e¤©Ê³¯z¥i¯à¥]¬A¦ý¤£©ó¡G Ãö©ó¤½¥q·~°È¾Ô²¤©MÁ{§Éµo®ip¹ºªºÁn©ú¡F¤½¥qªºp¹º ¶}µo¨Ã°Ó·~¤ÆASLAN004©MASLAN003¡F ASLAN004©MASLAN003ªº¦w¥þ©Ê©M¦³®Ä©Ê¡F³o ¤½¥q°w¹ïASLAN004©MASLAN004ªºÁ{§É¸ÕÅç©MÁ{§É¸ÕÅçµ²ªGªºp¹º©M¹w´Á®É¾÷ ASLAN003;¤½¥q¦³ÃöºÊºÞ¤å¥ó©M§å㪺p¹º©M¹w´Á®É¾÷¡A¥H¤Î³W¼Ò ASLAN004©MASLAN003ªº¥«³õ¼Wªø¼ç¤O¡F ASLAN004§@¬°·s«¬¥ý¶i§Þ³Nªº¼ç¤O ¹v¦VIL-13RªºÃþ§ÜÅé¡A¦b¯SÀ³©Ê¥Öª¢¤¤¨ã¦³®t²§¤Æªº¥\®Ä©M¦w¥þ©Ê¡F©M ¤½¥q¬Û«H¨ä²{ª÷©M²{ª÷µ¥»ùª«±N¨¬¥H¬°2023¦~¤§«eªº·~°È´£¨Ñ¸êª÷¡C ¦ôp¡A¹w´ú©M¨ä¥L«e¤©Ê³¯z¬O°ò©óºÞ²z¼h·í«eªº°²³]©M ¹ï¥¼¨Ó¨Æ¥ó©MÁͶժº´Á±æ¡A³o¨Ç¼vÅT©M¥i¯à¼vÅT¤½¥qªº·~°È¡A¾Ô²¤¡A¹BÀç©Î °]°È·~ÁZ¡A¨Ã©T¦³¦a¯A¤Î«¤jªº¤wª¾©M¥¼ª¾·ÀI»P¤£½T©w©Ê
Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic on the Company¡¦s business and the global economy; general market conditions; changes in the competitive landscape; and the Company¡¦s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company¡¦s US Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company¡¦s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on April 16, 2020. All statements other than statements of historical fact are forward-looking statements. The words ¡§believe,¡¨ ¡§may,¡¨ ¡§might,¡¨ ¡§could,¡¨ ¡§will,¡¨ ¡§aim,¡¨ ¡§estimate,¡¨ ¡§continue,¡¨ ¡§anticipate,¡¨ ¡§intend,¡¨ ¡§expect,¡¨ ¡§plan,¡¨ or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. Estimates, projections and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection or forward-looking statement.
¹ê»Úµ²ªG ¨Æ¥óµo¥Íªº®É¶¡¥i¯à»P«e¤©ÊÁn©ú¤¤¹w´Áªºµo¥Í«¤j¤£¦P¡A¨Ò¦p ³\¦h·ÀI©M¤£½T©w©Êªºµ²ªG¡A¥]¬AÁ{§É«eÆ[¹î¨ìªº·N¥~¦w¥þ©Ê©Î¥\®Ä¼Æ¾Ú ©ÎÁ{§É¬ã¨s¡FÁ{§É³¡¦ì¿E¬¡²v©ÎÁ{§É¸ÕÅç¤J²Õ²v§C©ó¹w´Á¡F³o COVID-19¤j¬y¦æ¹ï¤½¥q·~°È©M¥þ²y¸gÀÙªº¼vÅT¡FÁ`Å饫³õ±¡ªp¡F Ävª§®æ§½ªºÅܤơF¤½¥q¦³¯à¤OÀò±o¨¬°÷ªº¸êª÷¨Ó¬°¨ä¾Ô²¤´£¨Ñ¸êª÷ ©MÁ{§Éµo®ip¹º¡C¨ä¥L¥i¯à¾ÉP¹ê»Úµ²ªG»P©ú¥Ü©Î·t¥Üªº¦]¯À¦³©Ò¤£¦Pªº¦]¯À ¤½¥q¦b¬ü°êÃÒ¨é¥æ©ö©eû·|ªº¤å¥ó¤¤´yz¤F¦¹Ãþ«e¤©ÊÁn©ú¤¤ªº¤º®e ©M³ø§i¡]©eû·|¤å¥ó½s¸¹001-38475¡^¡A¥]¬A¤½¥q¦V¬ü°ê´£¥æªº20-Fªí¦~«×³ø§i ÃÒ¨é¥æ©ö©eû·|©ó2020¦~4¤ë16¤éµo¥¬¡C°£¾ú¥v¨Æ¹ê³¯z¥~¡A©Ò¦³¨ä¥L³¯z§¡¬° «e¤©Ê³¯z¡C ¡§¬Û«H¡¨¡A¡§¥i¯à¡¨¡A¡§¥i¯à¡¨¡A¡§¥i¯à¡¨¡A¡§±N¡¨¡A¡§¥Ø¼Ð¡¨¡A¡§¦ôp¡¨¡A¡§Ä~Äò¡¨µ¥¦r²´ ¡§¹w´Á¡¨¡A¡§¥´ºâ¡¨¡A¡§´Á±æ¡¨¡A¡§p¹º¡¨©Î³o¨Ç³N»yªº§_©wµü¡A¥H¤Îªí¹F¥H¤U¤º®eªºÃþ¦üªíz ¥¼¨Ó¨Æ¥ó©Îµ²ªGªº¤£½T©w©Ê¦®¦b½T©w¦ôp¡A¹w´ú©M¨ä¥L«e¤©Ê ³¯z¡C¦ôp¡A¹w´ú©M¨ä¥L«e¤©Ê³¯z¶È¥Nªí°µ¥X¤§¤éªº»¡ªk¡A ¨Ã¥B¡A°£ªk«ßn¨Dªº½d³ò¥~¡A¤½¥q¤£©Ó¾á§ó·s©Î¼f¬d¥ô¦ó¦ôºâªº¸q°È¡A ¹w´ú©Î«e¤©Ê³¯z¡C
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