Affibody have shared long-term 46-week data from a global Phase 2 trial of izokibep in psoriatic arthritis (PsA).
The randomized double-blind, placebo-controlled, Phase 2 clinical trial evaluated the safety and efficacy of izokibep dosed 80 mg every two weeks (Q2W) or 40 mg Q2W, versus placebo Q2W, in adult patients with active PsA. The global study assessed various endpoints including the American College of Rheumatology (ACR) response, the Psoriasis Area and Severity Index (PASI) score and the Leeds Enthesitis Index (LEI). At Week 16, the placebo cohort transitioned to 80 mg izokibep Q2W. The trial treatment period continued for up to 46 weeks.
“The 46-week data announced by our partner ACELYRIN demonstrate continued and marked improvements in key areas of psoriatic arthritis including joint pain, skin psoriasis, and enthesitis,” says Nikolai Brun, CMO of Affibody
The Phase 2 trial
Through week 46 of this Phase 2 trial, izokibep was generally well-tolerated – in line with previous trials of izokibep. The most common adverse event (AE) was injection site reactions. Injection site reactions were localized reactions, with the majority graded mild-to-moderate in severity, generally 25-30 mm in diameter, and typically presented within the first few injections, after which they declined in incidence. In the trial, one serious adverse event (vulvar cancer) which was determined to be potentially drug-related was observed.
The full 46-week data from this trial will be presented at a future scientific meeting. Izokibep is currently being evaluated in an ongoing Phase 2b/3 trial in PsA evaluating a range of doses, including higher doses than in the reported Phase 2 trial.
Photo of Nikolai Brun: Affibody