Late-stage clinical biopharma company Acelyrin, Inc. (SLRN) Monday said that there was a programming error in its drug trial of a treatment for psoriatic arthritis.
Acelyrin said that recently it identified clinical trial execution errors involving its Contract Research Organization (CRO) and one of the vendors engaged by the CRO.
The company confirmed that the protocol, which outlined dosing sequence, was correct. However, Acelyrin's protocol was programmed incorrectly by the vendor, resulting in a sequencing error that went further unidentified through the providers' testing processes.
As a result, some patients in the 160mg Q2W and 80mg Q4W arms received placebo and active treatment in random order rather than in an alternating pattern as intended. Importantly, there is no risk to patient safety resulting from the sequencing errors and no patient received more active treatment than was already included in the protocol for the most frequent 160mg QW dosing arm.
The programming error has been addressed and the dosing sequence has been corrected.
"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.
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