Prenumeration
Stockholm, Sweden, December 10, 2024. Affibody’s licensee ACELYRIN, INC. today announced that the Phase 2b/3 trial of izokibep in non-infectious, non-anterior uveitis did not meet the primary endpoint. Izokibep was well-tolerated in the trial, with a favorable safety profile consistent with previous data and the IL-17A class.
The primary endpoint, treatment failure rate at 24 weeks, was 45.0% for izokibep and 50.7% for placebo (p-value: 0.4914). Additionally, no key secondary endpoints achieved statistical significance. While IL-17 inhibition is an extensively validated mechanism of action across a range of chronic inflammatory conditions, including hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), it remains to be proven in uveitis.
“The outcome in the uveitis trial is in stark contrast to the best-in-class results from late-stage trials of izokibep in both HS and PsA that were recently presented at the EADV and EULAR conferences respectively,” said David Bejker, Chief Executive Officer of Affibody. “While the positive HS and PsA data support a path to approval for izokibep, ACELYRIN has determined that a program of this breadth and size is best brought to market by a larger organization. Affibody continues to believe that izokibep can become a game-changing drug in the dermatology field, particularly for the significant number of patients debilitated by HS.”