ACELYRIN Fails to Meet Primary Endpoint in Phase 2b/3 Study
ACELYRIN, Inc., (Nasdaq: SLRN) has failed to meet the primary endpoint in Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa (HS). Response rates for izokibep showed a clear dose-effect favoring 160mg weekly dosing, and no safety or tolerability limitations.
Shao-Lee Lin, MD, PhD, founder and CEO of ACELYRIN, said, “I would like to thank the patients and clinicians in this study, without whom we would not be able to continue to learn about how best to treat this debilitating disease. Although the overall study did not meet statistical significance, izokibep appears to be demonstrating consistent early and high orders of response for patients suffering from hidradenitis suppurativa without safety or tolerability limitation.”
The randomized double-blind, placebo-controlled, multi-center trial evaluated the safety and efficacy of izokibep dosed 160 mg weekly and every two weeks (Q2W), versus placebo, in 175 patients with moderate-to-severe HS.
The trial was conducted at 50 sites globally and assessed various efficacy endpoints, including the primary endpoint of HiSCR75 (Hidradenitis Suppurativa Clinical Response) at 16 weeks utilizing a non-responder imputation (NRI) analysis method.
HS is a chronic inflammatory skin condition causing lesions including deep-seated nodules and abscesses, draining tracts, and fibrotic scars.
The company’s cash, cash equivalents and short-term marketable securities totaled $823.0 million at June 30, 2023.
ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines.