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Acelyrin (NASDAQ:SLRN) said it is conducting a review of its Phase2/3 clinical trial for its drug izokibep in the treatment of psoriatic arthritis due to dose sequencing errors linked to a vendor working on the study.
In particular, Acelyrin said that a vendor engaged by the clinical research organization, or CRO, conducting the study incorrectly programmed the trial’s protocol, which resulted in some patients receiving placebo and active treatment dosing in random order rather than an alternating pattern. The dosing errors occurred in two arms of the four-arm study.
Acelyrin said was no risk to patient safety due to the error and that the sequencing order has been corrected. The company said it is working to “determine the implications” of the dosing issues in the two affected arms. It also plans to hire a third party to conduct an independent audit of the trials being conducted by the CRO, which also includes studies of the drug in the treatment of hidradenitis suppurativa, according to a company statement.
Based on the outcome of the review and planned audit, Acelyrin will then decide the best path forward for development of the product, including whether to transition ongoing studies to a new CRO. Acelyrin plans to report topline data from its study for psoriatic arthritis in Q1 2024, pending completion of the auditor’s evaluation.
Acelyrin added that it had $788.4M in cash as of Sept. 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, Acelyrin said it will no longer attend the Piper Sandler Annual Healthcare Conference on Nov. 28 and the Annual Evercore ISI HealthCONx Conference on Nov. 30.
Acelyrin went public in May through an IPO that raised $540M.
