Acelyrin, Inc. (NASDAQ: SLRN) has reported positive top-line results from its global phase 2b/3 clinical trial of Izokibep in psoriatic arthritis (psa). The study met the primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance. The trial had a low study discontinuation rate of less than 3%, and mild-to-moderate injection site reactions were observed with discontinuations due to ISR less than 2%.
Results from the trial showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and minimal disease activity relative to the phase 2 80 mg q2w dose. The favorable safety profile of Izokibep was consistent with the IL-17A class and previous experience, with no evidence of the safety liabilities observed with targeting IL-17A&F. There were two cases of mild candida and no cases of suicidal ideation/behavior, with pre-specified analyses supporting the potential for differentiation in enthesitis resolution.
The phase 2b/3 clinical trial enrolled 351 adult patients with active psa across 71 sites in the United States and Europe and randomized them across the four arms. The trial evaluated the safety and efficacy of Izokibep dosed subcutaneously 160 mg every week (qw) or every two weeks (q2w) and 80 mg every four weeks (q4w) versus placebo.
Philip Mease, MD, MACR, Director of Rheumatology Research at Swedish Medical Center, commented that the positive phase 2b/3 data reinforce the potential demonstrated in phase 2 for Izokibep to provide meaningful benefit in treating the debilitating signs and symptoms of active psoriatic arthritis in the joints and skin.
Shao-Lee Lin, MD, PhD, Founder and CEO of Acelyrin, expressed excitement about the continued progress with Izokibep in both psa and hs and the potential for developing it as an important new medicine for patients.
Today the company's shares have moved 7.9% to a price of $8.07. Check out the company's full 8-K submission here.
