Affibody’s Partner ACELYRIN Provides Update on Izokibep Clinical Development Program
Prenumeration
Solna, Sweden, November 27, 2023. Affibody’s partner ACELYRIN, INC. (“ACELYRIN”) today provided an update on its izokibep clinical development program, including the ongoing global Phase 2b/3 trial in psoriatic arthritis (“PsA trial”).
The ongoing PsA trial, initiated by ACELYRIN, is designed with four arms: 160mg dosed every week (QW), 160mg dosed every other week (Q2W), 80mg dosed every four weeks (Q4W) and placebo. ACELYRIN recently identified clinical trial execution errors involving its CRO and one of the vendors engaged by the CRO. ACELYRIN has 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.
ACELYRIN is working to determine the implications of the sequencing errors in the 160mg Q2W and 80mg Q4W arms. Based on ACELYRIN’s review to date and the fact that the placebo and 160mg QW arms were designed for consistent weekly dosing, ACELYRIN has no reason to believe the 160mg QW and placebo arms are impacted.
ACELYRIN will contract with a third party-party to conduct an independent audit of the trials being conducted by the CRO for ACELYRIN. 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.
“We are disappointed by this information”, said David Bejker, CEO of Affibody. “We are, however, committed to fully understand these issues in the clinical development of izokibep and remain convinced that izokibep is a potentially very important treatment for multiple immunologic conditions with strong and differentiated Phase 2 data in PsA.”
Affibody announced in November 2020 the initiation of a Phase 2 trial of izokibep in PsA. This Phase 2 trial has generated differentiated 16- and 46-week data. Long-term efficacy results from the same trial presented recently at the American College of Rheumatology annual meeting showed that with longer duration of treatment, patients experienced durable and deepening resolution of disease.