LOS ANGELES - ACELYRIN, INC. (NASDAQ:SLRN), a biopharmaceutical company specializing in immunology, reported Monday that their Phase 2b/3 trial of izokibep for psoriatic arthritis (PsA) achieved its primary endpoint. The trial demonstrated significant clinical improvement at 16 weeks compared to placebo, with the drug meeting the ACR50 efficacy benchmark.
Patients receiving izokibep showed enhanced responses at more stringent thresholds, such as ACR70 and PASI100, a measure of complete skin clearance, and Minimal Disease Activity. These outcomes suggest a potential advancement in the treatment of PsA, a chronic inflammatory condition that affects both joints and skin.
The study encompassed 351 adult patients across 71 sites in the United States and Europe. Participants were administered izokibep subcutaneously at varying doses and frequencies, with the 160 mg weekly and every other week dosages showing notable improvements over the Phase 2 dose of 80 mg every two weeks.
Notably, the trial maintained a low discontinuation rate of under 3%, and the safety profile of izokibep was consistent with the IL-17A inhibitor class, without the safety concerns associated with IL-17A&F targeting.
While the trial did not achieve statistical significance in overall enthesitis resolution, due to a high placebo response, izokibep did show meaningful resolution in patients with the highest burden of enthesitis. This is a significant finding as it represents an effect not previously reported by other treatments. Additional data from the trial is expected to be presented at future scientific meetings.
The efficacy of izokibep in treating psoriatic arthritis's debilitating symptoms, including joint and skin manifestations as well as enthesitis, was underscored by Philip Mease, MD, MACR, Director of Rheumatology Research at Swedish Medical Center. He noted that longer-term treatment with izokibep could lead to further improvements over time.
Shao-Lee Lin, MD, PhD, Founder and CEO of ACELYRIN, expressed optimism about the drug's continued progress, highlighting the clinically meaningful responses observed across various efficacy measures. The company anticipates that izokibep could offer a differentiated benefit for patients, positioning it as a potentially important new medicine for PsA treatment.
The information presented is based on a press release statement from ACELYRIN, INC.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.