Acelyrin Inc. (NASDAQ:SLRN) has announced a dosing error in its ongoing global Phase 2b/3 trial of izokibep for psoriatic arthritis (PsA), leading to a stock price decline. The error, stemming from incorrect programming by Clinical Research Organization (CRO) Fortrea (NASDAQ:FTRE), affected the dosing sequence for some patients in the 160mg every other week (Q2W) and 80mg every four weeks (Q4W) dosing arms.
Dosing Error Details
According to the SEC filing, Fortrea incorrectly programmed the protocol, causing some patients in the affected arms to receive placebo and active treatment in a random order instead of the intended alternating pattern. Acelyrin clarified that the error posed no risk to patients, as no one received more active ingredients than the protocol permitted. The company has since corrected the dosing sequence and believes that other trial arms were unaffected.
Ongoing Review and Independent Audit
This issue surfaces after Acelyrin reported in September 2023 that izokibep failed to meet the primary endpoint in the late-stage portion of a Phase 2b/3 study for patients with moderate to severe hidradenitis suppurativa (HS). The company is conducting a comprehensive review of its ongoing izokibep trials, including the operational execution by the CRO. As part of this review, Acelyrin will engage a third party to conduct an independent audit of trials managed by the CRO, encompassing both the HS and PsA trials.
Psoriatic Arthritis Trial Data Timeline
Acelyrin anticipates reporting top-line data from its PsA trial in the first quarter of 2024, pending the completion of the third-party auditor's evaluation.
