Acelyrin Inc SLRN updated its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (PsA trial).
In its SEC filing, Acelyrin confirmed that the protocol outlining the dosing sequence was correct for the PsA trial. However, Clinical Research Organization Fortrea FTRE incorrectly programmed the company's protocol.
As a result, some patients in the 160mg every other week (Q2W) dosing arm and 80mg every four weeks (Q4W) dosing arm received a placebo and active treatment in random order rather than in an alternating pattern as intended.
Acelyrin said there was no risk to patients due to the error, and no one received more active ingredients than the protocol allowed.
The error has now been addressed, and the dosing sequence has been fixed. Acelyrin has no reason to believe the other arms of the trial were in any way affected.
In September 2023, Acelyrin reported that its lead prospect izokibep, failed the late-stage portion of a phase 2b/3 study in patients with moderate to severe hidradenitis suppurativa (HS study). The drug candidate did not beat the placebo on the primary endpoint.
Acelyrin's wide-ranging review of the ongoing izokibep trials, including operational execution by the CRO, is continuing. Acelyrin will contract with a third party to conduct an independent audit of the trials being conducted by the CRO for Acelyrin, including the HS trial and the PsA trial.
Pending completion of the evaluation from the third-party auditor, Acelyrin plans to report top-line data from its PsA trial in the first quarter of 2024.
Price Action: SLRN shares are down 25.2% at $6.51, and FTRE is down 6.60% at $31.34 on the last check Tuesday.
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