Affibody, ACELYRIN, and Inmagene Biopharmaceuticals, have announced that a 16-week, global, Phase 2 clinical trial of izokibep in patients with psoriatic arthritis (PsA) met its primary endpoint in a pre-specified interim analysis.
The double-blind, placebo-controlled Phase 2 clinical trial, designed and conducted by Affibody, 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 interim analysis primary endpoint was ACR50 at 16 weeks. No new safety issues were identified.
“Psoriatic arthritis is a painful and debilitating inflammatory disease of the peripheral joints, skin, and nails, and can also involve the spine. We are pleased this Phase 2 trial met its primary endpoint while also confirming the safety of izokibep,” says Nikolai Brun, chief medical officer (CMO) of Affibody.
“There are now two positive Phase 2 trials with izokibep, one in PsA and one in psoriasis, both demonstrating the safety and efficacy of izokibep and highlighting its potential as a therapeutic across multiple IL-17 driven diseases,” says Paul Peloso, CMO of ACELYRIN. “We look forward to the trial continuation and presenting results in a future scientific forum.”
Support the strategy
More than 300 patients have been exposed to izokibep to date, many for up to three years. The interim PsA Phase 2 trial data confirm the safety profile of izokibep and support the strategy of fully evaluating IL-17A inhibition in pursuit of transformative efficacy across many disease states, according to the companies.
ACELYRIN holds worldwide rights to izokibep except development and commercialization by Inmagene in selected Asian countries, including China, Hong Kong, Macau, South Korea, and Taiwan, and excluding Japan, and commercialization by Affibody in the Nordic countries.
Photo of Nikolai Brun: Affibody