ACELYRIN Announces Positive Phase 3 Izokibep Results in Hidradenitis Suppurativa to be Presented at EADV 2024

26 September 2024
ACELYRIN, INC., a clinical biopharmaceutical company specializing in advanced-stage immunology treatments, has disclosed optimistic outcomes from its global Phase 3 clinical trial of izokibep for patients suffering from moderate-to-severe hidradenitis suppurativa (HS). These findings will be presented as a late-breaking oral presentation at the upcoming 2024 European Academy of Dermatology and Venereology event, scheduled for September 25-28, 2024, in Amsterdam, Netherlands.

The presentation, titled "Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Moderate-to-Severe Hidradenitis Suppurativa: Week 12 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study," will be delivered by Kim Papp, M.D., Ph.D., President and Director of Research at Probity Medical Research, Inc. This session will take place on Wednesday, September 25, 2024, from 4:00 to 4:15 PM CEST.

Dr. Shephard Mpofu, Chief Medical Officer of ACELYRIN, highlighted the significance of the trial results. "The global Phase 3 clinical trial of izokibep as a treatment for HS displayed statistically significant and clinically relevant responses across multiple efficacy endpoints, especially in higher-order responses such as HiSCR90 and HiSCR100, by the 12-week mark," said Dr. Mpofu. "We are optimistic that these data could pave the way for regulatory approval in this indication and are excited about presenting the data at this crucial dermatology forum."

Izokibep is a small protein therapeutic specifically engineered to inhibit IL-17A with high potency. Its design includes a tight binding affinity, the potential for strong tissue penetration due to its small molecular size—approximately one-tenth the size of a monoclonal antibody—and an albumin binding domain that prolongs its half-life. Izokibep is currently undergoing multiple late-stage trials for conditions including moderate-to-severe hidradenitis suppurativa (HS), moderate-to-severe psoriatic arthritis (PsA), and noninfectious uveitis. Data from Phase 3 trials for HS and PsA have shown clinical responses comparable to next-generation IL-17 inhibition methods. However, ACELYRIN has announced that it will discontinue internal development of izokibep for HS and PsA.

ACELYRIN, INC. (Nasdaq: SLRN) is committed to offering patients groundbreaking treatment options by identifying, acquiring, and expediting the development and commercialization of transformative medicines. The company's leading program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R, which is currently under investigation for treating thyroid eye disease.

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