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LEO Pharma reveals positive top-line Phase III results for tralokinumab
¤¦³Á¥Ö½§¬ì±M®aLEO Pharmaªí¥Ü¡A¦±§´³æ§Ü¬O¤@ºØ¬ã¨s©Êªº¡A§¹¥þ¤H·½¤Æªº³æ§J¶©§ÜÅé¡A¥i¯S²§©Ê¤¤©M¥Õ¤¶¯À13¡]IL-13¡^²ÓM¦]¤l¡A¦b¨ä¤T¶µÃöÁ䪺III´Á¬ã¨s¡]ECZTRA 1-3¡^¤¤§¡¹F¨ì¤F©Ò¦³¥Dn©M¦¸n²×ÂI¥Î©óªvÀø¦¨¤Hªº¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢¡]AD¡^¡C¦b¬ã¨s´Á¶¡¡AÁ`ªº¤£¨}¨Æ¥óµo¥Í²v¦btralokinumab©M¦w¼¢¾¯¤§¶¡¬O¥i¤ñªº¡C
IL-13¬O2«¬ª¢¯gªºÃöÁäÅX°Ê¦]¯À¡A¦bAD¤¤°_¥Dn§@¥Î¡CAD¬Oµo¹F°ê®a¤¤³Ì±`¨£ªºª¢¯g©Ê¥Ö½§¯f¡A¦b¬ü°ê¡A¥[®³¤j¡A¼Ú¬w©M¤é¥»¡A¼vÅT¦h¹F5¢Hªº¦¨¦~¤H¡C AD¥i¯à¹ïæ±Äo¡AºÎ¯v¤£¨¬©M¥i¨£¯f¨_³y¦¨ªºªÀ·|¦Ã¦W¤Æ¡A¹ï±wªÌªº°·±d²£¥Í«¤jªºt±¼vÅT¡C
LEO Pharma©ó2016¦~±qªü´µ§Q±d¡]LSE¡GAZN¡^Àò±o¤F¥Ö½§¯e¯f¤¤ªºtralokinumabªºÅv§Q¡A¸Ó¥æ©ö¯A¤Î¦V^°ê-·ç¨å»sÃÄ¥¨ÀY¹w¥I1.15»õ¬ü¤¸¡A¥H¤Î°ª¹F10»õ¬ü¤¸ªº°Ó·~¬ÛÃö¨½µ{¸O©M²£«~¾P°âªº¯S³\Åv¨Ï¥Î¶O¤ñ¨Ò¤£¶W¹L¦Ê¤À¤§¤Q¡Cªü´µ§Q±d¦b©I§l¨t²Î¯e¯f©M¥Ö½§¯f¾Ç¥H¥~ªº¥ô¦ó¨ä¥L¾AÀ³¯g¤è±«O¯d¹ï¦±§´¯]³æ§Üªº©Ò¦³Åv§Q¡C
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¦¹¥~¡A´X¤Ñ«e¡A¬ü°êÂåÀø«O°·¥¨ÀY±j¥Í¤½¥q¡]NYSE¡GJNJ¡^ºX¤UªºJanssen Biotech¦¬ÁʤFXBiotech¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GXBIT¡^ªº·s«¬§ÜÅébermekimab¡A¸Ó§ÜÅé¥i¤¤©M¥Õ¤¶¯À-1£\¡]IL-1⍺¡^¡C
LEO Pharma¥þ²y¬ãµo°õ¦æ°ÆÁ`µôKim Kjoeller³Õ¤h»¡¡G¡§ AD³B©ó¤¤«×¦Ü««×§Î¦¡¡A·|¾ÉP±wªÌÃø¥H§Ô¨üªº¤Ï´_µo§@¯gª¬¡C¡¨ ¡§¾¨ºÞ³Ìªñ¦³¤F·sªºªvÀø¤èªk¡A¦ý§Ṳ́£Â_Å¥¨ì¥@¬É¦U¦aªºÂåÀø«O°·±M·~¤Hûªº·N¨£¡A»Ýn§ó¦hªºªvÀø¿ï¾Ü¨Ó¸Ñ¨M¨C¦ì±wªÌªº¤£¦PÅé¼x©M¯gª¬¡C³o¨Ç¬ã¨sµ²ªG¥O§ÚÌ·P¨ì¹ª»R¡A³o¨Çµ²ªGªí©ú¡A¹ï©ó±w¦³³oºØ¨Ï¤H°I®zªººC©Ê¥Ö½§¯fªº±wªÌ¡A¦±§´¯]³æ§Ü¥i¯à¬O¤@ºØ¦³®Ä¥B@¨ü©Ê¨}¦nªºªø´ÁªvÀø¤è®×¡C¡¨
LEO Pharmap¹º¦b2020¦~¦VºÊºÞ¾÷ºc´£¥æ¥Î©óªvÀø¤¤¦Ü««×ADªº¦¨¦~±wªÌªºtralokinumabªº¤W¥«±ÂÅv¥Ó½Ð¡A¨Öp¹º±N³o¨Ç¬ã¨sªº¸Ô²Óµ²ªG´£¥æ¬ì¾Ç¤j·|¨Ã¦b¦P¦æµû¼f¤¤µoªí¥H¤Î2020¦~ªºÂå¾Ç´Á¥Z¡C
www.thepharmaletter.com/article/leo-pharma-reveals-positive-top-line-phase-iii-results-for-tralokinumab
Danish dermatology specialist LEO Pharma says that tralokinumab ¡V an investigational, fully-human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine ¡V met all primary and secondary endpoints in its three pivotal Phase III studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo.
IL-13 is a key driver of the type 2 inflammation that plays a major role in AD, which is the most common inflammatory skin disease in the developed world, affecting up to 5% of adults across the USA, Canada, Europe and Japan. AD can have a significant, negative impact on patients¡¦ well-being, primarily due to distressing itch, sleep deprivation and social stigmatization due to visible lesions.
LEO Pharma acquired rights for tralokinumab in skin diseases in 2016 from AstraZeneca (LSE: AZN), in a deal that involved and upfront payment of $115 million to the Anglo-Swedish pharma major, as well up to $1 billion in commercially-related milestones and up to mid-teen tiered percentage royalties on product sales. AstraZeneca retains all rights to tralokinumab in respiratory disease and any other indications outside of dermatology.
Competitive sector According to analytics firm GlobalData, the atopic dermatitis market will grow from $6.4 billion in 2017 to $18.3 billion in 2027 across the seven major markets (7MM = USA, France, Germany, Italy, Spain, the UK, and Japan), expanding at a compound annual growth rate (CAGR) of 11.1%.
The sector has a significant heavyweight on the market in the form of Sanofi (Euronext: SAN) and Regeneron¡¦s (Nasdaq: EGN) Dupixent (dupilumab), which is already generating blockbuster revenues and peak sales of $11 billion are projected.
A late-stage IL-13 is Dermira¡¦s (Nasdaq: DERM) lebrikizumab, which was acquired from Roche (ROG: SIX) after the latter failed in its effort in asthma.
Also, Janssen Biotech, part of US healthcare giant Johnson & Johnson (NYSE: JNJ), just a few days ago acquired XBiotech¡¦s (Nasdaq: XBIT) novel antibody, bermekimab, that neutralizes interleukin-1 alpha (IL-1⍺).
¡§In its moderate-to-severe form, AD can cause unbearable recurring symptoms for patients,¡¨ said Dr Kim Kjoeller, executive vice president, global R&D at LEO Pharma. ¡§Despite recent treatment advances, we consistently hear from healthcare professionals around the world that additional treatment options are needed to address the different signs and symptoms for each patient. We are encouraged by these study results, which show that tralokinumab could be an efficacious and well-tolerated long-term treatment solution for patients living with this debilitating chronic skin disease,¡¨ he added.
LEO Pharma is planning to submit marketing authorization applications for tralokinumab for the treatment of adult patients with moderate-to-severe AD to regulatory agencies in 2020 and plans to submit the detailed results of these studies for presentation at scientific congresses and publication in peer-reviewed medical journals in 2020 as well.
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ASLAN004 ª½±µÂê©wIL13/¨üÅé£\1¦¸³æ¦ì (¥çºÙ¬°IL-13R£\1) ¤§¥þ¤H·½³æ®è§ÜÅé ,¦³¾÷·|Àu©ó Lebrikizumab ¹vÂIIL-13.
Lebrikizumab 250 mg¨C¨â¶g¤@¦¸¡G •±µ¨ü¨F¥q«×³æ§Ü(Lebrikizumab)ªvÀøªº±wªÌ¤¤¦³60.6¢Hªº±wªÌ¦bEASI-75¤¤»P°ò½u¬Û¤ñ°§C¤F¦Ü¤Ö75¢H¡A¦Ó¦w¼¢¾¯²Õ¬°24.3¢H¡]p = 0.0005¡^¡C
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-------------------------- 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
Dermira Announces Positive Topline Results from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis ˆý „J „´ „¨ „¥ †qEmail ƒ}Print Friendly †WShare
March 18, 2019 07:00 ET | Source: Dermira, Inc. Ãö©óLebrikizumab 2b´Á¬ã¨s ¦b©Ò¦³µû¦ôªº¾¯¶q¤¤¡Alebrikizumab¦b¥Dn²×ÂI¡]±q°ò½u¨ì²Ä16¶g¡^ªºEASIµû¤À¥§¡ÅܤƦʤÀ¼ÆÅã¥Ü¥X¾¯¶q¨Ì¿à©Ê©M²Îp¾ÇÅãµÛªº§ïµ½¡C ±µ¨ü125²@§Jlebrikizumabªº±wªÌªºEASIµû¤À§ïµ½¬°62.3¢H¡C ¡]mg¡^¡A¨C¥|©P¡]p = 0.0165¡^¡A±µ¨üLebrikizumab 250 mgªº±wªÌ¡A¨C¥|©P69.2¢H¡]p = 0.0022¡^¡A±µ¨ülebrikizumab 250 mg¡A¨C¨â¶gªº±wªÌ72.1¢H¡]p = 0.0005¡^¬Û¤ñ¤§¤U¡A±µ¨ü¦w¼¢¾¯ªº±wªÌ¬°41.1¢H¡C
»P¦w¼¢¾¯¬Û¤ñ¡A¨C¨â©Î¥|©P¥H250 mg¾¯¶qªº¨Ó¤ñ¯]³æ§ÜªvÀøªº±wªÌ¦bªvÀø16¶g«á»P¦w¼¢¾¯¬Û¤ñ¦b¨ä¥LÃöÁä¥\®Ä«ü¼Ð¤W¦³²Îp¾Ç¤WªºÅãµÛ§ïµ½¡A¥]¬A¡G
Lebrikizumab 250²@§J¨C¥|©P¤@¦¸¡G •®Ú¾Ú¬ã¨sªÌªº¾ãÅéµû¦ô¡]IGA¡^µû¤À¬°0©Î1¡A33.7¢Hªº¨Ó¥¬¦C³æ§ÜªvÀøªº±wªÌ¹ê²{¤F¥Ö½§¯fÅܪº²M°£©Îªñ¥G²M°£¡A»P°ò½u¬Û¤ñ°§C¤F¦Ü¤Ö2ӦʤÀÂI¡A¦Ó¨Ï¥Î¸ÓÃĪ«ªº¤ñ¨Ò¬°15.3¢H¦w¼¢¾¯¡]p = 0.0392¡^¡C
•lebrikizumabªvÀøªº±wªÌªºEASIµû¤À¡]EASI-75¡^»P°ò½u¬Û¤ñ°§C¤F¦Ü¤Ö75¢H¡A¦Ó¦w¼¢¾¯²Õ¬°24.3¢H¡]p = 0.0021¡^¡C •36.1¢Hªº¨Ìªi³æ§ÜªvÀø±wªÌªºEASIµû¤À¡]EASI-90¡^»P°ò½u¬Û¤ñ°§C¤F¦Ü¤Ö90¢H¡A¦Ó¦w¼¢¾¯²Õ¬°11.4¢H¡]p = 0.0062¡^¡C
Lebrikizumab 250 mg¨C¨â¶g¤@¦¸¡G •³q¹LIGAµû¤À¬°0©Î1µû¦ô¡A¦³46.6¢Hªº¨Ó¥¬¦C³æ§ÜªvÀøªº±wªÌ¹ê²{¤F¥Ö½§¯fÅܪº²M°£©Îªñ¥G²M°£¡A»P°ò½u¬Û¤ñ´î¤Ö¤F¦Ü¤Ö2ӦʤÀÂI¡A¦Ó¦w¼¢¾¯²Õ¬°15.3¢H¡]p = 0.0023 ¡^¡C
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125 mg lebrikizumabµ¹ÃÄÁuªº¦¸n²×ÂI¥¼¹F¨ì²Îp¾Ç·N¸q¡C
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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.
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1. Dupilumab 2014,11¤ë,20¤é¡AÀòFDA ,BTD ¬ð¯}©ÊÀøªk , 2017¦~¡A3¤ëÀòAD²Ä¤@±iÃĵý¡A2019¦~¡A¦ô¥þ²y½æ¥X±N¶W¹L22»õ¬ü¤¸¡]«e3q¤w½æ¥X15.6»õ¬ü¤¸¡C2020¦~¦ô±N½æ¥X40¤@45»õ¬ü¤¸¡C¡^ And Regeneron Announce That Dupilumab Has Received FDA Breakthrough Therapy Designation In Atopic Dermatitis Paris and Tarrytown, New York - November 20, 2014 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) that are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. The designation is based on previously announced positive results from Phase 1 and 2 clinical trials.
Ãö©óDupilumab©MIL-4 / IL-13«H¸¹¶Ç¾É Dupilumab¬O¤@ºØ§¹¥þ¤H·½ªº³æ§J¶©§ÜÅé¡A°w¹ïªº¬OIL-4¨üÅé£\¨È°ò¡A¥¦ªýÂ_¤F¨Ó¦ÛIL-4©MIL-13ªº«H¸¹¶Ç¾É¡C IL-4©MIL-13¬O¤Þµo©Mºû«ùTh2¡]2«¬»²§U©ÊT²ÓM¡^§K¬ÌÀ³µª©Ò»ÝªºÃöÁä²ÓM¦]¤l¡ATh2³Q»{¬°¬O¹L±Ó©Êª¢¯gªºÃöÁä³~®|¡C
About Dupilumab and IL-4/IL-13 Signaling Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation.
Dupilumab was created using Regeneron¡¦s pioneering VelocImmuneR technology and is being co-developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis. Dupilumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority |
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Dermira Receives Fast Track Designation from FDA for Lebrikizumab for the Treatment of Atopic Dermatitis Business Wire Business Wire¡EDecember 10, 2019
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finance.yahoo.com/news/dermira-receives-fast-track-designation-133000115.html
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 that the
U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lebrikizumab, its novel, investigational treatment being evaluated for patients with moderate-to-severe atopic dermatitis.
Fast Track is a designation granted by the FDA intended to facilitate the drug development process and expedite the review of therapies to treat serious conditions and fill an unmet medical need, including by demonstrating an advantage over currently available therapy. The goal of the Fast Track process is to ensure important new treatments reach patients as quickly as possible.
We are pleased that the FDA granted lebrikizumab its Fast Track designation and recognizes the unmet need for patients living with moderate-to severe atopic dermatitis and the potential for lebrikizumab to offer a treatment for this serious condition, said Tom Wiggans, chairman and chief executive officer of Dermira. This Fast Track designation puts us one step closer to potentially delivering a new therapeutic option more quickly to patients should the results from earlier Phase 2 studies be confirmed in the ongoing Phase 3 studies assessing the safety, efficacy and tolerability of the investigational therapy.
Lebrikizumab is currently being evaluated in two Phase 3 studies, ADvocate 1 and ADvocate 2, to confirm its safety and efficacy in adolescent and adult patients, ages 12 years and older, with moderate-to-severe atopic dermatitis.
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 a range of signs and symptoms, including rashes on the skin that often cover much of the body, as well as intense, persistent itching. The 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, 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 underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
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1.2017/08/08 Dermira¦Vù¤óROCHE ,ÁʶR Lebrikizumab¥þ²yAD¶}µoÅv«eª÷8000¸U¬ü¤¸¡A2018¦~¦A¤ä¥I5500¸U¬ü¤¸¡C ±Ò°Ê²Ä¤@Ó3´Á¤§«e¤ä¥I4000¸U¬ü¤¸¡A¦b¬Y¨Ç¦a°Ï¨ú±oÃÄÃÒ©Mº¦¸°Ó·~¾P°â¨ã¦³¨½µ{¸O·N¸q®É¤ä¥I2.1»õ¬ü¤¸¡A°£¶¡½è©ÊªÍ¯f¥H¥~ªº¾AÀ³¯gªº²b¾P°âÃB¹F¬Y¨Ç»ùȳ̰ª¹F¨ì10.25»õ¬ü¤¸,¦Xp¬ù14»õ¬ü¤¸,¥[¾P°â¤À¼í<= 10%. Áô§t28»õ¬ü¤¸³Ì°ª¾P°âÃB.
2.2019/02 ,Dermira ¦A±Â¥X¼Ú¬wLebrikizumab °Ó·~¤ÆÅv¤Oµ¹Almirall,¤½¥q.
Out-License and Other Agreements Almirall Agreement
2019¦~6¤ë30¤é¬°1.10»õ¬ü¤¸¡A¨½µ{ª÷+¾P°â¨½µ{ª÷?+¾P°â¤À¼í? ¨ä¤¤¥]¬A¡G¡]i¡^3000¸U¬ü¤¸ªº«e´Á´ÁÅv¶O; ¡]ii¡^5,000¸U¬ü¤¸ªº´ÁÅv¦æÅv¶O¡F ¡]iii¡^3000¸U¬ü¤¸ªº¨½µ{¸O
§ÚÌ©ó2019¦~2¤ë»PAlmirallñq¤F¤@¥÷´ÁÅv©M³\¥i¨óij¡]¡§ Almirall¨óij¡¨¡^¡A®Ú¾Ú¸Ó¨óij¡AAlmirallÀò±o¤F¤@¶µ ¶}µo¥Î©óªvÀø©Î¹w¨¾¥Ö½§¯f¾AÀ³¯g¡]¥]¬A¦ý¤£©ó¯SÀ³©Ê¥Öª¢¡^ªº°Ç¥¬¯]³æ§Üªº¿W®a³\¥iÅv¡F ¥H¤Î¦b¼Ú¬w±N¥Î©óªvÀø©Î¹w¨¾©Ò¦³¾AÀ³¯gªº¨Ó¥¬¦C³æ§Ü°Ó·~¤Æ¡]¡§ Lebrikizumab¼Ú·ù³\¥i¡¨¡^¡C §@¬°¥æ´«¡A§Ú̦¬¨ì¤F¤£¥i°h´Úªº ©ó2019¦~3¤ë¤ä¥I3,000¸U¬ü¤¸ªº«e´Á´ÁÅv¶O¥Î¡C2019¦~6¤ë¡AAlmirall®Ú¾Ú¡m Almirall¨óij¡n¦æ¨Ï¤F¨ä´ÁÅv¡C»P¦¹½m²ß¦³Ãö¡A Almirall¦V§Ṳ́ä¥I¤F5,000¸U¬ü¤¸ªº´ÁÅv¦æÅv¶O¡A§Ṳ́w©ó2019¦~7¤ë¦¬¨ì¸Ó¶O¥Î¡C®Ú¾ÚAlmirall¨óijªº±ø´Ú¡A§Ú̦³Åv¦¬¨ú ¦b¹F¦¨¬Y¨Ç¶}µo¡AºÊºÞ©M¾P°â¨½µ{¸O«áÃB¥~¤ä¥Iªº´Ú¶µ¡A¥]¬A»P§Ú̵o°_ªº3,000¸U¬ü¤¸¬ÛÃöªº ¬Y¨Ç3´ÁÁ{§É¬ã¨s¥H¤Î¯S³\Åv¨Ï¥Î¶O¥Nªí¤F¼Ú¬wlebrikizumab²b¾P°âÃBªº¦Ê¤À¤ñ¡C 2019¦~10¤ë¡A§Ú̱ҰʤF²Ä¤@Ó lebrikizumab 3´ÁÁ{§É¬ã¨sIJµo¤FAlmirall 750¸U¬ü¤¸ªº¨½µ{¸O¥I´Ú¡C 750¸U¬ü¤¸ªº¨½µ{¸O¥I´Ú¬OAlmirall¦³¸q°È´N¬Y¨Ç¬Y¨Ç3´ÁÁ{§É¬ã¨sªº±Ò°Ê¦V§Ṳ́ä¥IÁ`p3000¸U¬ü¤¸¡C
¦bAlmirall®Ú¾Ú¡m Almirall¨óij¡n¿ï¾Ü¦æ¨Ï¨ä¿ï¾ÜÅv«á¡A§Ú̽T©w¤F¥H¤U©ú½Tªº¼i¬ù¸q°È¡G¡]i¡^ ¥æ¥ILebrikizumab¼Ú·ù³\¥i¡A¥H¤Î¡]ii¡^¶i¦ælebrikizumab²Ä¤T¶¥¬q¶}µop¹º¡C§Ú̽T©wºI¦Ü6¤ëªº¥æ©ö»ù®æ 2019¦~30¤é¬°1.10»õ¬ü¤¸¡A¨ä¤¤¥]¬A¡G¡]i¡^3000¸U¬ü¤¸ªº«e´Á´ÁÅv¶O; ¡]ii¡^5,000¸U¬ü¤¸ªº´ÁÅv¦æÅv¶O¡F ¡]iii¡^3000¸U¬ü¤¸ªº¨½µ{¸O »P¬Y¨Ç3´ÁÁ{§É¬ã¨sªº±Ò°Ê¦³Ãö¡A³o¨Ç¬ã¨s³Q½T©w¬°¤£¨ü¨î¡C¨ä¥L¥¼¨Ó¼ç¦bªººÊºÞ¨½µ{¸O¬O ³Q»{¬°¬O§¹¥þ¨üªº¡A¦]¬°§Ú̽T©w¹ê²{³o¨Ç¨½µ{¸O¨ú¨M©ó¥¼¨ÓªºÁ{§É¸ÕÅç©MºÊºÞ¬O§_¦¨¥\ §åã¡A³o¤£¦b§Ú̪º±±¨î½d³ò¤º¡A¥Ø«e©|¤£½T©w¡C §Ú̹wp¡A°ò©ó¾P°âªº¨½µ{¸O©M¯S³\Åv¨Ï¥Î¶O¥I´Ú±N¦b µo¥Í¾P°â©Î¹F¨ì¨½µ{¸O¡C§Ú̱N¦b¨CÓ³ø§i´Á«·sµû¦ô¥æ©ö»ù®æ¡C
We entered into an option and license agreement with Almirall in February 2019 (¡§Almirall Agreement¡¨), under which Almirall acquired an option to exclusively license rights to develop lebrikizumab for the treatment or prevention of dermatology indications, including, but not limited to atopic dermatitis, and commercialize lebrikizumab for the treatment or prevention of all indications in Europe (¡§Lebrikizumab EU License¡¨). In exchange, we received a non-refundable upfront option fee of $30.0 million in March 2019. In June 2019, Almirall exercised its option pursuant to the Almirall Agreement. In connection with this exercise, Almirall paid us an option exercise fee of $50.0 million, which we received in July 2019. Under the terms of the Almirall Agreement, we are entitled to receive additional payments upon the achievement of certain development, regulatory and sales milestones, including $30.0 million in connection with the initiation by us of certain Phase 3 clinical studies, as well as royalty payments representing percentages of net sales of lebrikizumab in Europe. In October 2019, we initiated the first lebrikizumab Phase 3 clinical study, which triggered a $7.5 million milestone payment by Almirall to us. The $7.5 million milestone payment is part of the $30.0 million in aggregate that Almirall is obligated to pay us in connection with the initiation of certain Phase 3 clinical studies. Upon Almirall¡¦s election to exercise its option pursuant to the Almirall Agreement, we identified the following distinct performance obligations: (i) the delivery of the Lebrikizumab EU License and (ii) the conduct of the lebrikizumab Phase 3 development program. We determined that the transaction price as of June 30, 2019 was $110.0 million, consisting of: (i) the $30.0 million upfront option fee; (ii) the $50.0 million option exercise fee; and (iii) the $30.0 million in milestones in connection with the initiation of certain Phase 3 clinical studies, which were determined to not be constrained. Other future potential regulatory milestones were considered to be fully constrained, as we determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, which are not within our control and are uncertain at this stage. We expect that the sales-based milestone and royalty payments will be recognized when the sales occur or the milestone is achieved. We will re-evaluate the transaction price each reporting period.
§Ú̮ھڨⶵ¼i¬ù¸q°È¤¤¨C¤@¶µªº¦ôp¿W¥ß°â»ù¨Ó¤À°t¥æ©ö»ù®æ¡C§Ú̽T©w¤F¿W¥ß °ò©ó²{ª÷¬y¶q§é²{ªkªºLebrikizumab¼Ú·ù³\¥iªº¾P°â»ù®æ¡A¨Ã¦Ò¼{¤F¥H¤U´XÓ¦]¯À¡A¥]¬A¦ý¤£©ó¡G¦ôp¥«³õ »Ý¨D¡A»s³y©M¨ÑÀ³¦¨¥»¡A¶}µo©M°Ó·~¤Æ¦¨¥»¡A§é²{²v¡A¶}µo©M§åã®É¶¡ªí¥H¤Î§Þ³N¥i¯à©Ê ©MºÊºÞ¤è±ªº¦¨¥\¡C¤À°tµ¹§Ú̪ºLebrikizumab¼Ú·ù³\¥i¼i¬ù¸q°Èªº¥æ©ö»ù®æ³¡¤À·|¦b¥ß§Y°O¿ý Almirall©ó2019¦~²Ä¤G©u«×¦æ¨Ï¨ä¿ï¾ÜÅv¡A¦]¬°Lebrikizumab¼Ú·ù³\¥i¥Nªí¤F¦Û2005¦~°_ÂàÅýªº¥\¯à©Êª¾ÃѲ£Åv Almirallªº´ÁÅv¦æÅv¤é´Á¬°2019¦~6¤ë¡C§Ú̮ھڥH¤U±¡ªp½T©w¤Flebrikizumab 3´Á¶}µop¹ºªº¿W¥ß°â»ù¡G n°õ¦æªºªA°Èªº©Ê½è¡A¬ÛÃö¶O¥Îªº¦ôºâ¥H¤ÎÃþ¦üªA°Èªº²Ä¤T¤è¶O²v¡C ¥æ©ö»ù®æ¤¤¤À°tµ¹§Ú̪º³¡¤À lebrikizumab²Ä¤T¶¥¬q¶}µop¹ºªº¼i¬ù¸q°È¨Ï¥Î¿é¤Jªk§@¬°lebrikizumab²Ä¤T¶¥¬q¶}µo½T»{¬°¦¬¤J ¸Óp¹º¥¿¦b§¹¦¨¡A¨ãÅéµøLebrikizumab¶}µop¹ºÁ`¶O¥Î©M¨CӮɴÁªº¹ê»Ú¶O¥Î¦Ó©w¡C ¦b¦¹´Á¶¡ ºI¦Ü2019¦~9¤ë30¤éªº¤TÓ¤ë¡A§Ú̶}©l´£¨Ñ¬ãµoªA°È¨Ã¶}©l½T»{»Plebrikizumab²Ä¤T¶¥¬q¬ÛÃöªº¦¬¤J ¶}µop¹º¼i¦æ¸q°È¡C ºI¦Ü2019¦~9¤ë30¤éªº¤TÓ¤ë©M¤EÓ¤ë¡A§Ṳ́À§O½T»{¤F130¸U¬ü¤¸©M5990¸U¬ü¤¸ªº¨ó§@©M³\¥i¦¬¤J ¦b§Ú̪ºÂ²©ú¦X¨Ö¹BÀç³øªí¤¤»P¡m Almirall¨óij¡n¬ÛÃö¡CºI¦Ü2019¦~9¤ë30¤é¡A¤w±N2,010¸U¬ü¤¸°O¬°»¼©µ¦¬¤J ¦b²©úªº¦X¨Ö¸ê²£t¶Åªí¤W¡A¹wp±N¦b³Ñ¾lªº²Ä3¶¥¬q¶}µo´Á¤º½T»{¬°¨ó§@©M³\¥i¦¬¤J¡C
We allocated the transaction price based on the estimated stand-alone selling prices of each of the two performance obligations. We determined the stand-alone selling price for the Lebrikizumab EU License based on a discounted cash flow approach and considered several factors including, but not limited to: estimated market demand, manufacturing and supply costs, development and commercialization costs, discount rate, development and approval timelines and probabilities of technical and regulatory success. The portion of the transaction price allocated to our Lebrikizumab EU License performance obligation was recorded immediately upon Almirall¡¦s exercise of its option in the second quarter of 2019, as the Lebrikizumab EU License represents functional intellectual property that was transferred as of the date of Almirall¡¦s option exercise in June 2019. We determined the stand-alone selling price for our lebrikizumab Phase 3 development program based on the nature of the services to be performed, estimates of the associated costs and third-party rates for similar services. The portion of the transaction price allocated to our lebrikizumab Phase 3 development program performance obligation is being recognized as revenue using the input method as the lebrikizumab Phase 3 development program is being completed, subject to changes in estimated total lebrikizumab development program costs and actual costs incurred during each period. During the three months ended September 30, 2019, we began performing research and development services and started recognizing revenue related to the lebrikizumab Phase 3 development program performance obligation. For the three and nine months ended September 30, 2019, we recognized $1.3 million and $59.9 million, respectively, as collaboration and license revenue related to the Almirall Agreement in our condensed consolidated statements of operations. As of September 30, 2019, $20.1 million was recorded as deferred revenue on the condensed consolidated balance sheets and is expected to be recognized as collaboration and license revenue over the remaining Phase 3 development period.
s23.q4cdn.com/229915008/files/doc_financials/2019/q3/eed4f82f-3329-4341-9c3f-3b2ff6647f9c.pdf
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¯SÀ³©Ê¥Öª¢¤£¶È¬O¨àµ£µo§@ªº¯e¯f¡F¨C4¦W¦¨¤H¤¤´N¦³1¦W³ø§i³Ìªì¯gª¬¬°¦¨¤Hµo§@¡C 10¡B11
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¾¨ºÞ¬ã¨s¦Ê¤À¤ñ¦³©Ò¤£¦P¡A¦ý¦hºØ±Ú©Î¥Õ¤H¦¨¦~¤H¤¤¯SÀ³©Ê¥Öª¢ªº±w¯f²v³Ì°ª¡C 2¡B9¡B14
»P¥Õ¤H¨àµ£¬Û¤ñ¡A«D¸Ç¬ü°ê¤H/¶Â¤H©M¦è¯Z¤ú¸Ç¨àµ£ªºAD§ó¬°ÄY«¡C 8¡B14
¦b¬ü°ê¹Ò¥~¥X¥Íªº«Ä¤l¦b¬ü°ê¥Í¬¡10¦~«á±w¤WADªº·ÀI°§C50¢H¡C 15
±w¦³ADªºÓÅ餤¦³80¢Hªº¤H·|¦b6·³¤§«eµo¯f¡A¦Ó¥B¥Ø«eªº¼Æ¾Úªí©ú¡A¦Ü¤Ö80¢Hªº¤H·|¦b«C¬K´Á©Î¦¨¦~«á¡§ªø¥X¡¨ AD¡C 16¡B17
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Prevalence of Childhood & Adult Atopic Dermatitis (AD) Approximately 9.6 million U.S. children under the age of 18 have AD, and one-third have moderate to severe disease. 5, 7, 8
The prevalence of childhood AD has steadily increased from 8% to ~12% since 1997. 4
An estimated 16.5 million U.S. adults (7.3%) have AD that initially began at >2 years of age, with nearly 40% affected by moderate or severe disease. 9
Atopic dermatitis is not solely a disease of childhood onset; 1 in 4 adults report adult-onset of initial symptoms. 10, 11
Atopic dermatitis affects a similar number of male and female children, however, studies have shown it is more common in adult females than males. 2, 5, 6, 8, 9, 12, 13
In the U.S., AD affects more African-American/black children and European-American children compared to Hispanic children. 5, 7, 12
Although study percentages vary, adults that are multiracial or white tend to have the highest prevalence of atopic dermatitis. 2, 9, 14
African-American/black and Hispanic children tend to have more severe AD compared to white children. 8, 14
Children born outside the U.S. have a 50% lower risk of developing AD that increases after living in the U.S. for 10 years. 15
80% of individuals affected with AD experience disease onset prior to 6 years of age, and current data suggests at least 80% will ¡§outgrow¡¨ their AD by adolescence or adulthood. 16, 17
Children with more severe, persistent AD have a higher risk for prolonged disease, although AD may persist regardless of severity. 17, 18
nationaleczema.org/research/eczema-facts/
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Dermira ¤µ¦~9¤ë¥÷ªº¤½¥q²¤¶
p.3 Roche ±ÂÅvlebrikizymab ªvÀøADµ¹Dermira ,¤£¥]¬A¼Ú¬w°Ï p.20¡C2027¦~AD(¬ü°ê/¼Ú¬w/¤é¥»¤T¤j)¥«³õ±N¹F 210»õ¬ü¤¸¡A2019¦~¶È20»õ¬ü¤¸¡C
Driven by the advent of new, systemic therapies addressing unmet needs in moderate-to-severe patients, major- marketsalesofbranded,systemic therapies for AD are projected to exceed $21B by 2027
p.26 ¾÷Âà¹Ï(duplimab/Lebrikizumab/Tralokinumab
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ASLAN PHARMACEU/ADR (NASDAQ:ASLN) Upgraded to ¡§Overweight¡¨ by Piper Jaffray Companies
Piper Jaffray Companies upgraded shares of ASLAN PHARMACEU/ADR (NASDAQ:ASLN) from a neutral rating to an overweight rating in a research note issued to investors on Monday, The Fly reports. The brokerage currently has $8.00 price target on the stock.
mitchellmessenger.com/2019/12/06/aslan-pharmaceu-adr-nasdaqasln-upgraded-to-overweight-by-piper-jaffray-companies.html
¾Ú¡m The Fly¡n³ø¾É¡A¶g¤@¦b¤@¥÷¬ã¨s³ø§i¤¤¡APiper Jaffray Companies±NASLAN PHARMACEU / ADR¡]NASDAQ¡GASLN¡^ªºªÑ²¼µû¯Å±q¤¤©Êµû¯Å¤W½Õ¦Ü¶W«¡C ¸Ó¨é°Ó¥Ø«e¹ï¸ÓªÑªº¥Ø¼ÐªÑ»ù¬°8.00¬ü¤¸¡C
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sec.report/Document/0001193125-19-306309/ Form 424B5 Aslan Pharmaceuticals Ltd
Prospectus [Rule 424(b)(5)]
SEC.report / ASLAN Pharmaceuticals Ltd / Form 424B5 / (Filer)
Published: 2019-12-04 17:18:12
ASLAN004 ¡V Multiple Ascending Dose Clinical Trial in
Moderate-to-Severe Atopic Dermatitis
In October 2019, we announced the enrolment of the first patient in our MAD clinical trial testing the
first-in-class therapeutic antibody ASLAN004 in
moderate-to-severe atopic dermatitis patients. The randomised, double-blind, placebo-controlled clinical trial will evaluate three doses of ASLAN004 delivered subcutaneously and will be followed by an expansion cohort at the most efficacious dose. Each dose cohort will contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain 12 patients on ASLAN004 and six patients on placebo. Patients are dosed weekly for eight weeks to determine safety and the maximum efficacy of ASLAN004. The trial 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. After completion of the MAD trial, we plan to initiate a phase 2b dose-range finding trial in atopic dermatitis patients.
On December 2, 2019, we reported preliminary unclean blinded data from the first three patients treated with the lowest dose of ASLAN004, 200mg, that had completed at least one month of dosing. ASLAN004 was well-tolerated and, to date, there have been no serious adverse events or treatment discontinuations. The EASI scores of the three patients were reduced by 85%, 70% and 59% and the EASI score continued to fall at four weeks with maximal efficacy expected at six to eight weeks. Corresponding changes were seen in other measures of efficacy. The data monitoring committee is scheduled for late December, after which the second dose cohort is expected to open.
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.
page s-3
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Dermira Gains Rights to Roche IL-13 Inhibitor Lebrikizumab in Up-to-$1.4B Partnership August 8, 2017
Dermira¤µ¤Ñªí¥Ü¡A¥¦¤w¦P·N±qù¤ó¤Î¨äGenentech¤l¤½¥qÀò±o¥þ²y¿W®aÅv§Q¡A¥H¶}µo©M°Ó·~¤Ælebrikizumab¡Alebrikizumab¬O¤@ºØ°w¹ï¥Õ¤¶¯À13¡]IL-13¡^ªº³æ§J¶©§ÜÅé¡A¦b¤j¦h¼Æ¾AÀ³¯g¤¤¡A³oµ§¥æ©ö¥i¯à²£¥Í°ª¹F1.4¬ü¤¸ªº¦¬¯q¤Q»õ¬ü¤¸ªº»sÃÄ¥¨ÀY¡C
®Ú¾Ú¨â®a¤½¥qªº³\¥i¨óij¡ADermira±NÀò±o¯SÀ³©Ê¥Öª¢©M°£¶¡½è©ÊªÍ¯f¡]¦p¯Sµo©ÊªÍÅÖºû¤Æ¡^¥H¥~ªº©Ò¦³¨ä¥L¾AÀ³¯g¤¤ªº¨Ó¥¬¦C³æ§ÜªºÅv§Q¡Aù¤ó±N«O¯d¨äÅv§Q¡C
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¦ý¬O¡ALAVOLTA I¸ÕÅç¹F¨ì¤F¨ä¥Dn²×ÂI¡A³oªí©ú¦å²Mperiostin©Î¦å²G¶Ý»Ä©Ê²É²ÓM¤ô¥¸û°ªªº¤Hªºý³Ý«æ©Êµo§@²vÅãµÛ°§C¡A¨Ã¥B³q¹L¤@¬íÄÁªº±j¨î©I®ð¶q´ú¶q¡AªÍ¥\¯àÅãµÛ§ïµ½¡]FEV1¡^-¾¨ºÞÆ[¹î¨ìªº®ÄªG¤p©óII´Á¬ã¨s¤¤¬Ý¨ìªº®ÄªG¡C
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www.genengnews.com/topics/drug-discovery/dermira-gains-rights-to-roche-il-13-inhibitor-lebrikizumab-in-up-to-1-4b-partnership/
Dermira said today it has agreed to obtain exclusive, worldwide rights from Roche and its Genentech subsidiary to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin-13 (IL-13), for most indications, in a deal that could generate up to $1.4 billion for the pharma giant.
Under the companies¡¦ licensing agreement, Dermira will gain rights to lebrikizumab in atopic dermatitis and all other indications except interstitial lung diseases, such as idiopathic pulmonary fibrosis¡Xindications to which Roche will retain rights.
Roche tried and failed last year to advance lebrikizumab in asthma, acknowledging disappointing results from two Phase III trials in February 2016. The LAVOLTA II trial missed its primary endpoint by showing rates of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils that were not statistically significant.
However, the LAVOLTA I trial met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, as well as significant improvement in lung function as measured by forced expiratory volume in one second (FEV1)¡Xthough observed effects were less than seen in Phase II studies.
Today, Dermira said it planned to launch a Phase IIb dose-ranging study assessing lebrikizumab in adults with moderate-to-severe atopic dermatitis in the first quarter of 2018. The goal of the study will be to optimize the dose of lebrikizumab for an eventual Phase III clinical program.
Preliminary design elements of the Phase IIb dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than were explored in previous atopic dermatitis studies, according to Dermira.
¡§The addition of this program to our development portfolio represents an important step toward our goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions,¡¨ Dermira chairman and CEO Tom Wiggans said in a statement.
Promising Preclinical, Early Clinical Results
Dermira CMO Eugene Bauer, M.D., added that lebrikizumab has generated promising preclinical and early clinical data that have suggested that higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis¡Xwhile potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies.
Dermira has agreed to pay Roche an initial $80 million this year and $55 million in 2018¡Xas well as payments tied to achieving milestones.
The milestone payments include $40 million upon the initiation of Dermira¡¦s first Phase III clinical study, up to $210 million upon achieving regulatory and first commercial sale milestones in certain territories, and up to $1.025 billion upon achieving net sales thresholds for lebrikizumab in indications other than interstitial lung disease.
Under their collaboration, Roche retains exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.
Dermira added that it also agreed to pay Roche royalties totaling percentages of net sales ranging from the high single-digits to the high teens.
The deal is expected to close in the third quarter, subject to expiration or termination of the waiting period under the Hart¡VScott¡VRodino Antitrust Improvements Act, as amended.
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dupilmab /Lebrikizumab/Tralokinumab / ¾÷Âà¹Ï |
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¥\¯à IL-13¹ï§K¬Ì²ÓMªº§@¥Î»Pºò±K¬ÛÃöªº²ÓM¦]¤lIL-4¬Û¦ü¡C[4]µM¦Ó¡AIL-13³QÃhºÃ¬O¹L±Ó©Êª¢¯g¦b³\¦h²Õ´¤¤¤Þ°_ªº¥Í²zÅܤƪº¥Dn¤¶½è¡C[4] ¾¨ºÞIL-13¥Dn»P®ð¹D¯e¯fªº»¤µo¦³Ãö¡A¦ý¥¦¤]¨ã¦³§Üª¢¯S©Ê¡C[4] IL-13¦b©I§l¹D¤¤»¤¾É¤F¤@Ãþ³J¥Õ½è°¸Ñ酶¡AºÙ¬°°ò½èª÷ÄݳJ¥Õ酶¡]MMP¡^¡C[4]³o¨Ç酶¬O»¤¾É¹ê½è©Êª¢©Ê²ÓM¦V®ðºÞµÄ¤º«Iŧ¨Ã²M°£«á©Ò¥²»Ýªº¡C[4]¦b¨ä¥L¦]¯À¤¤¡AIL-13»¤¾É³o¨ÇMMPsªº§@¥Î¬O¹w¨¾¹L«×²¿®§ªº¹L«×¹L±Ó©Êª¢¯gªº¾÷¨îªº¤@³¡¤À¡C[4] ¤wª¾IL-13·|»¤¾É³y¦å²ÓMµo¥ÍÅܤơA¦ý³o¨Ç§@¥Î¥i¯à¤£¦pIL-4«n[4]¡C¦¹¥~¡AIL-13¥i¥H»¤¾É¬¡¤Æªº¤HB²ÓM¤Àªc§K¬Ì²y³J¥ÕE¡]IgE¡^¡C[4] [7]±q¤p¹«Å餺§R°£IL-13¤£·|©úÅã¼vÅT±j®ÄÅÜÀ³ì»¤¾ÉªºTh2²ÓMµo¨|©Î§Üì¯S²§©ÊIgE¤ÏÀ³¡C[4]¬Û¤ñ¤§¤U¡AIL-4ªº¯Ê¥¢¨Ï³o¨Ç¤ÏÀ³¥¢¬¡¡C¦]¦¹¡AIL-13¦Ó¤£¬O²O¤Ú¼Ë²ÓM¦]¤l¡A¦b±NÅÜÀ³©Êª¢©Ê²ÓM³s±µ¨ì»P¥¦Ì±µÄ²ªº«D§K¬Ì²ÓM¤W°_µÛ¤À¤l¾ô¼Ùªº§@¥Î¡A±q¦Ó§ïÅܤF¥Í²z¥\¯à¡C[4] IL-13ªº«H¸¹¶Ç¾É©l©ó»PIL-4¦@¨Éªº¦h¨È°ò¨üÅé¡C[7]¸Ó¨üÅé¬O¥Ñ£\IL-4¨üÅé¡]IL-4R£\¡^©M£\¥Õ¤¶¯À13¨üÅé¡]IL-13R1¡^²Õ¦¨ªº²§¤G»EÅé¨üÅé½Æ¦Xª«¡C[7] IL-13¹ïIL-13R1ªº°ª¿Ë©M¤O¾ÉP¥¦ÌªºÁä§Î¦¨¡A³o¶i¤@¨B¼W¥[¤F»PIL-4R1§Î¦¨²§·½¤G»EÅ骺¥i¯à©Ê¥H¤Î2«¬IL-4¨üÅ骺²£¥Í¡C²§¤G»E§@¥Î¦P®É¿E¬¡STAT6©MIRS¡C[7] STAT6«H¸¹¶Ç¾É¦b¤Þµo¹L±Ó¤ÏÀ³¤¤«Ü«n¡C[7] IL-13ªº¤j³¡¤À¥Íª«¾Ç®ÄÀ³¡A»PIL-4¤@¼Ë¡A³£»P³æÓÂà¿ý¦]¤l¡A«H¸¹Âà¾É¤l©MÂà¿ý¿E¬¡¦]¤l6¡]STAT6¡^¬ÛÃö¡C[7]¥Õ²ÓM¤¶¯À13¤Î¨ä¬ÛÃö¨üÅé»PIL-4¨üÅ骺£\¨È°ò¡]IL-4R£\¡^¤¹³\STAT6ªº¤U´å¿E¬¡¡C[9]¨üÅéM½è¥½ºÝªºJAK Janus¿E酶³J¥Õ¥i¨ÏSTAT6ÁC»Ä¤Æ¡AµM«á§Î¦¨¬¡¤Æªº¦P«¬¤G»EÅé¨ÃÂà¹B¦Ü²ÓM®Ö¡C[9]¤@¦¸¡ASTAT6²§¤G»EÅé¤À¤l¦b²ÓM®Ö¤¤½Õ¸`²ÓMÃþ«¬ªº°ò¦]ªí¹F¡A³oºØ°ò¦]ªí¹F¹ï©ó±J¥D§K¬Ì¨¾¿m©M¹L±Ó©Êª¢¯g¤ÏÀ³¡]¦pTh2ªº§Î¦¨¡^¤§¶¡ªº¥¿Å¦ÜÃö«n¡C[9]³o¥i¯à¬O¥Ñ±¹ïAla°ò¦]¤Þ°_ªº¹L±Ó¤ÏÀ³¤Þ°_ªº¡C IL-13ÁÙ»P¥t¤@ºØºÙ¬°IL-13R£\2ªº¨üÅéµ²¦X¡C[10] IL-13R£\2¡]¼Ð°O¬°»¤»ç¨üÅé¡^·½¦ÛTh2²ÓM¡A¬O¤@ºØ¦h®Ä©Ê§K¬Ì½Õ¸`²ÓM¦]¤l¡C[10] IL-13¹ïIL-13R£\2ªº¿Ë©M¤O¤j©ó¹ïIL-13Ra1ªº¿Ë©M¤O¡]50¿¡^¡C[10] IL-13R£\2¨È°ò¶È»PIL-13µ²¦X¡A¨Ã¥H½¤µ²¦X©M¥i·»©Ê§Î¦¡¦s¦b©ó¤p¹«¤¤¡C[10]¦b¤HÃþ¨ü¸ÕªÌ¤¤¥¼ÀË´ú¨ì¥i·»§Î¦¡ªºIL-13R£\2¡C[10]¹ï¨ã¦³IL-13R£\2µL®Ä°ò¦]®yªºIL-13Âà°ò¦]¤p¹«ªÍ³¡ªº¬ã¨sªí©ú¡AIL-13R£\2¯Ê¥FÅãµÛ¼W±j¤FIL-13©Î§Z²M³J¥Õ»¤¾ÉªºªÍ³¡ª¢¯g©M«¶ì¡C[10]¤j¦h¼Æ¥¿±`²ÓM¡A¨Ò¦p§K¬Ì²ÓM©Î¤º¥Ö²ÓM¡Aªí¹FªºIL-13¨üÅé¤ô¥«D±`§C©ÎµLªkÀË´ú¡C[10]¬ã¨sªí©ú¡A»P¥¿±`¹ï·Ó®ð¹D¦¨ÅÖºû²ÓM¬Û¤ñ¡A¤Hý³Ý®ð¹D¦¨ÅÖºû²ÓM¤¤IL-13R£\2ªº²ÓMªí±ªí¹F°§C¡C[10]³o¤ä«ù¤FIL-13R£\2¬OIL-13»¤¾Éªº¤ÏÀ³ªºt½Õ¸`¾¯³o¤@°²³]¡A¨Ã»¡©ú¤FTGF-£]1ªº²£¥Í©M½¦ì¦b¤p¹«ªÍ³¡ªº¨I¿nÅãµÛ°§C¡C[10] ¥Õ²ÓM¤¶¯À13¦bªMª¬²ÓM¤Æ¥Í¤¤°_ÃöÁä§@¥Î¡C[11]ªMª¬²ÓM¥Rº¡Öß³J¥Õ¡]MUC¡^¡C[11] MUC5ACÖß³J¥Õ5AC¬OªMª¬²ÓMªº¾®½¦ª¬Öß³J¥Õ²£ª«¡C[11]¥Õ¤¶¯À13»¤¾ÉªMª¬²ÓM¤À¤Æ¡A¨Ã¤¹³\¦b®ðºÞ¤W¥Ö¤¤²£¥ÍMUC5AC¡C[11] 15-Lipoxygenase-1¡]15LO1¡^¬O¯×ªÕ»Ä¥NÁ¤¤ªº¤@ºØ酶¡A¥¦ªº¥NÁ²£ª«15-HETE¦bý³Ý¤¤°ª«×ªí¹F¡]¾ÉPMUC5AC¹L«×ªí¹F¡^¡A¨Ã¥Ñ¤H®ð¹D¤W¥Ö¤¤ªºIL-13»¤¾É²ÓM¡CÀHµÛªMª¬²ÓM¼Æ¶qªº¼W¥[¡A¤ä®ðºÞ¤º·|²£¥Í¹L¦hªºÖß²G¡C[11] MUCÀx¦s©M¤ÀªcÅܤƪº¥\¯à«áªG¦³§U©óý³Ý±wªÌµo¥Í¦UºØÁ{§É²§±`ªº¯f²z¥Í²z¾÷¨î¡A¥]¬A·ð²G²£¥Í¡A®ð¹DÅܯ¶¡A´c¤Æ©MªÍ¥\¯à¥[³t³à¥¢¡C[11] ¦¹¥~¡AIL-13¤wÅã¥Ü¥X¦b¥H2«¬²ÓM¦]¤l¡]¨Ò¦p¡^¤É°ª¬°¯S¼xªº¦hºØ¯e¯f¹Lµ{¤¤»¤¾É¦³®ÄªºÅÖºû¤Æµ{§Ç
en.wikipedia.org/wiki/Interleukin_13
Interleukin 13 (IL-13) is a protein that in humans is encoded by the IL13 gene.[4][5][6] IL-13 was first cloned in 1993 and is located on chromosome 5q31 with a length of 1.4kb.[4] It has a mass of 13 kDa and folds into 4 alpha helical bundles.[7] The secondary structural features of IL-13 are similar to that of Interleukin 4 (IL-4); however it only has 25% sequence homology to IL-4 and is capable of IL-4 independent signaling.[7][4][8] IL-13 is a cytokine secreted by T helper type 2 (Th2) cells, CD4 cells, Natural killer T cell, Mast cell, Basophil cells, Eosinophil cells and Nuocyte cells.[7] Interleukin-13 is a central regulator in IgE synthesis, goblet cell hyperplasia, mucus hypersecretion, airway hyperresponsiveness, fibrosis and chitinase up-regulation.[7] It is a mediator of allergic inflammation and different diseases including asthma.[7]
Functions IL-13 has effects on immune cells that are similar to those of the closely related cytokine IL-4.[4] However, IL-13 is suspected to be central mediator of the physiologic changes induced by allergic inflammation in many tissues.[4] Although IL-13 is associated primarily with the induction of airway disease, it also has anti-inflammatory properties.[4] IL-13 induces a class of protein-degrading enzymes, known as matrix metalloproteinases (MMPs), in the airways.[4] These enzymes are required to induce aggression of parenchymal inflammatory cells into the airway lumen, where they are then cleared.[4] Among other factors, IL-13 induces these MMPs as part of a mechanism that protects against excessive allergic inflammation that predisposes to asphyxiation.[4] IL-13 is known to induce changes in hematopoietic cells, but these effects are probably less important than that of IL-4.[4] Furthermore, IL-13 can induce immunoglobulin E (IgE) secretion from activated human B cells.[4][7] Deletion of IL-13 from mice does not markedly affect either Th2 cell development or antigen-specific IgE responses induced by potent allergens.[4] In comparison, deletion of IL-4 deactivates these responses. Thus, rather than a lymphoid cytokine, IL-13 acts more prominently as a molecular bridge linking allergic inflammatory cell to the non-immune cells in contact with them, thereby altering physiological function.[4] The signaling of IL-13 begins through a shared multi-subunit receptor with IL-4.[7] This receptor is a heterodimer receptor complex consisting of alpha IL-4 receptor (IL-4R£\) and alpha Interleukin-13 receptor (IL-13R1).[7] The high affinity of IL-13 to the IL-13R1 leads to their bond formation which further increase the probability of a heterodimer formation to IL-4R1 and the production of the type 2 IL-4 receptor. Heterodimerization activates both the STAT6 and the IRS.[7] STAT6 signaling is important in initiation of the allergic response.[7] Most of the biological effects of IL-13, like those of IL-4, are linked to a single transcription factor, signal transducer and activator of transcription 6 (STAT6).[7] Interleukin-13 and its associated receptors with £\ subunit of the IL-4 receptor (IL-4R£\) allows for the downstream activation of STAT6.[9] The JAK Janus kinase proteins on the cytoplasmic end of the receptors allows for the phosphorylation of STAT6, which then forms an activated homodimer and are transported to the nucleus.[9] Once, in the nucleus, STAT6 heterodimer molecule regulates gene expression of cell types critical to the balance between host immune defense and allergic inflammatory responses such as the development of Th2.[9] This can be resulted from an allergic reaction brought about when facing an Ala gene. IL-13 also binds to another receptor known as IL-13R£\2.[10] IL-13R£\2 (which is labelled as a decoy receptor) is derived from Th2 cells and is a pleotropic immune regulatory cytokine.[10] IL-13 has greater affinity (50-times) to IL-13R£\2 than to IL-13Ra1.[10] The IL-13R£\2 subunit binds only to IL-13 and it exists in both membrane-bound and soluble forms in mice.[10] A soluble form of IL-13R£\2 has not been detected in human subjects.[10] Studies of IL-13 transgenic mice lungs with IL-13R£\2 null loci indicated that IL-13R£\2 deficiency significantly augmented IL-13 or ovalbumin-induced pulmonary inflammation and remodeling.[10] Most normal cells, such as immune cells or endothelial cells, express very low or undetectable levels of IL-13 receptors.[10] Research has shown that cell-surface expression of IL-13R£\2 on human asthmatic airway fibroblasts was reduced compared with expression on normal control airway fibroblasts.[10] This supported the hypothesis that IL-13R£\2 is a negative regulator of IL-13¡Vinduced response and illustrated significantly reduced production of TGF-£]1 and deposition of collagen in the lungs of mice.[10] Interleukin-13 has a critical role in the Goblet cell metaplasia.[11] Goblet cells are filled with mucin (MUC).[11] MUC5AC Mucin 5AC is a gel-like mucin product of goblet cells.[11] Interleukin-13 induces goblet cell differentiation and allows for the production of MUC5AC in tracheal epithelium.[11] 15-Lipoxygenase-1 (15LO1) which is an enzyme in the fatty acid metabolism and its metabolite, 15-HETE, are highly expressed in asthma (which lead to the overexpression of MUC5AC) and are induced by IL-13 in human airway epithelial cells. With the increasing number of goblet cells, there is the production of excessive mucus within the bronchi.[11] The functional consequences of the changes in MUC storation and secretion contributes to the pathophysiologic mechanisms for various clinical abnormalities in asthmatic patients including sputum production, airway narrowing, exacerbation and accelerated loss in lung function.[11] Additionally, IL-13 has been shown to induce a potent fibrogenic program during the course of diverse diseases marked by elevated Type 2 cytokines such as chronic schistosomiasis and atopic dermatitis among others. It has been suggested that this fibrogenic program is critically dependent on direct IL-13 signaling through IL-4R£\ on PDGFR£]+ fibroblasts.[12]
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æ±Äo³Q©w¸q¬°¤Þ°_¨íÀ¿¥Ö½§ªí±ªº¤£´r§Ö·Pı¡CºC©Êæ±Äo·|¼vÅT¥þ²y¬ù¤¤À¤§¤@ªº¤H¤f¡A¨Ã¥i¯àÄY«¼vÅT¤@Ó¤Hªº¥Í¬¡½è¶q¡C¦b³Ìªñªº¥H±wªÌ¬°¤¤¤ßªºÃĪ«¶}µo·|ij¤W±j½Õ¡Aæ±Äo³q±`»PºÎ¯v»Ùê¡A§íÆ{©MµJ¼{¦³Ãö¡A³Q»{¬°¬O¯SÀ³©Ê¥Öª¢³ÌÁc«ªº¤è±¤§¤@¡C
IL-13³Q»{¬°¬O¤@ºØ¥DnªºP¯f©Ê¤¶½è¡A³q¹L«P¶i2«¬ª¢¯g¨Ã¤¶¾É¨ä¹ï²Õ´ªº§@¥Î¨ÓÅX°Ê¯SÀ³©Ê¥Öª¢ªº¦UºØ¼x¥ü©M¯gª¬ªº¯f²z¥Í²z¾Çªº¦hӤ象A±q¦Ó¾ÉP¥Ö½§«Ì»Ù¥\¯à»Ùê¡Aæ±Äo¡A¥Ö½§¼W«p©M·P¬V¡C
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·ílebrikizumab³Q¤Þ¤J®É¡A¥¦·|ÅãµÛ§í¨î¤wª¾P±Ó쪺³o¨Ç¼W±jªºæ±Äo«H¸¹¡A³oªí©úlebrikizumab¦bª¢¯g©Ê¥Ö½§¯f¡]¦p¯SÀ³©Ê¥Öª¢¡^¤¤¦³¥i¯àªýÂ_¼W±jªºæ±Äo«H¸¹¡C³o¤@µo²{¤ä«ù¤F¦bDermiraªº2b´Á¾¯¶q½d³ò¬ã¨s¤¤µû¦ôªºlebrikizumab¦b¤¤¦Ü««×¯SÀ³©Ê¥Öª¢±wªÌ¤¤Æ[¹î¨ìªºµ²ªG¡A¸Ó±wªÌ¦bªvÀøªº²Ä¤G¤Ñ´N³ø§i¤Fæ±Äo¯gª¬ªº§ïµ½¡C
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Lebrikizumab¬O¤@ºØ·s¿oªº¬ã¨s©Ê³æ§J¶©§ÜÅé¡A³]p¥Î©ó¥H«D±`°ªªº¿Ë©M¤Oµ²¦XIL-13¡A¯S§O¬O¥i¨¾¤îIL-13R£\1/IL-4R£\²§¤G»EÅé½Æ¦Xª«ªº§Î¦¨©MÀH«áªº«H¸¹¶Ç¾É¡A±q¦Ó§í¨îIL-13ªº¥Íª«¾Ç®ÄÀ³¡C¦³°w¹ï©Ê©M°ª®Äªº®É©|¡C
Ãö©óæ±Äoªº¬ã¨sµ²ªG±N¥ÑDermira¬ã¨sÁ`ºÊ¶O¹F¡P¶ëºû§J¤Ú´µ¡]Ferda Cevikbas¡^³Õ¤h©ó2019¦~11¤ë19¤é¦b¦W¬°``¨Ã¦æ·|ij2¡Gæ±Äoªº·s¨üÅé¡A·s³~®|©M·s³~®|¡¦¡¦ªº·|ij¤Wµoªí¡C Cevikbas³Õ¤hÁÙ¾á¥ô¥»©¡·|ijªºÁp®u¥D®u¡C
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finance.yahoo.com/news/dermira-presents-scientific-research-findings-210500974.html
Dermira Presents New Scientific Research Findings from the Lebrikizumab Program at Leading International Itch Conference Business Wire Business Wire¡ENovember 15, 2019 MENLO PARK, Calif.--(BUSINESS WIRE)--
New findings in human sensory neurons highlight role of IL-13 in amplifying itch and lebrikizumab¡¦s role in inhibiting itch signals in atopic dermatitis
- Lebrikizumab Phase 3 program is currently enrolling adult and adolescent patients with moderate-to-severe atopic dermatitis
Dermira, Inc. (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 that new scientific findings highlighting the role of interleukin-13 (IL-13) in amplifying itch and the role lebrikizumab plays in reducing itch, will be presented at the 10th World Congress on Itch taking place November 17-19 in Sydney, Australia.
Itch is defined as an unpleasant sensation causing the desire to scratch the surface of the skin. Chronic itch affects approximately one-fifth of the global population and can have a significant impact on a person¡¦s quality of life. Itch is often associated with sleep disorders, depression and anxiety and is cited as one of the most burdensome aspects of atopic dermatitis, as underscored during a recent Patient-Focused Drug Development meeting.
IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
Key Research Findings
In laboratory experiments, cultured human sensory neurons were stimulated with IL-13 and subsequently introduced to several common itch-inducing agents (pruritogens), including histamine, serotonin and BAM8-22. The experiments demonstrated that IL-13 directly interacts with human sensory neurons, enhancing the itch induced by these itch-inducing agents.
When lebrikizumab was introduced, it significantly inhibited these potentiated itch signals to known pruritogens, demonstrating that lebrikizumab has the potential to block enhanced itch signals in inflammatory skin conditions such as atopic dermatitis. This finding supports the results observed in Dermira¡¦s Phase 2b dose-ranging study evaluating lebrikizumab in patients with moderate-to-severe atopic dermatitis, who reported improvements in itch symptoms as early as day two of treatment.
The findings will be submitted for publication in a peer-reviewed journal.
¡§People suffering from chronic itch associated with a host of dermatologic diseases often cite it as the most debilitating symptom,¡¨ said Luis Pena, chief development officer of Dermira. ¡§We believe these findings support our understanding of the role of lebrikizumab in reducing itch, helping to explain the improvement in itch observed in atopic dermatitis patients treated with the investigational therapy in our Phase 2b study.¡¨
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.
The findings on itch will be presented by Ferda Cevikbas, Ph.D., director of research at Dermira, on November 19, 2019 during a session titled, Concurrent Session 2: New receptors, channels and pathways for itch. Dr. Cevikbas is also serving as co-chair of the session.
Dr. Cevikbas is a noted expert in the pathophysiology of itch, having spent much of her career at the University of California, San Francisco, where she studied the differences and similarities between itch and pain. Prior to joining Dermira, she worked with a team of researchers at a biotechnology company exploring the mechanism of action for research compounds in inflammation and itch. Dr. Cevikbas is trained in dermatology and neuroscience.
¡§IL-13 has long been viewed as an important target in atopic dermatitis,¡¨ said Dr. Cevikbas. ¡§For the first time, IL-13 has been investigated in translational neuroscience studies in human sensory neurons to understand its role in chronic itch and the ability of lebrikizumab to block the effects of neuroactive IL-13. This translational work will inform future research and enhance our understanding of chronic itch in atopic dermatitis.¡¨
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