Acelyrin says ‘disappointed’ by developments in Izokibep clinical program

Acelyrin provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis, PsA trial. In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa . Given certain confounding factors observed in the trial, including responder discontinuations without adverse events and a marked increase in placebo rates arising in the latter half of the study, the Company implemented quality control measures above and beyond standard protocol for the ongoing open-label extension of the HS trial, the ongoing Phase 3 trial in HS, and the ongoing PsA trial. These trials are being conducted by the same Contract Research Organization CRO . The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program. “We are disappointed by these developments, especially for the patients who need better treatment options for psoriatic arthritis and hidradenitis suppurativa,” said Shao-Lee Lin, MD, PhD, founder and CEO of ACELYRIN. The Company reported cash of $788.4Mat September 30, which represents a multi-year runway to fund operations through key value-driving milestones across its portfolio of clinical programs. As a result of these developments, the Company will not attend Piper Sandler’s 35th Annual Healthcare Conference on Tuesday, November 28 or the 6th Annual Evercore ISI HealthCONx Conference on Thursday, November 30, 2023, as previously disclosed.