Affibody and Inmagene Biopharmaceuticals has announced that the FDA has cleared izokibep (ABY-035) to proceed to Phase 2 clinical development in Ankylosing Spondylitis (AS), a subset of Axial Spondyloarthritis (axSpA).

The partners are jointly developing izokibep to treat multiple autoimmune diseases, and Inmagene has taken the responsibility to manage the global clinical trials for axSpA.

“Obtaining FDA IND clearance is an important milestone for the izokibep program,” says Jean-Louis Saillot, Inmagene’s Chief Development Officer. “Working closely with our partner Affibody, the Inmagene team is excited to develop a potentially best-in-class treatment to improve the condition and life quality for AS patients.”

About the trial

The study is a one-year double-blind controlled trial in approximately 300 patients with active Ankylosing Spondylitis. The trial will evaluate the efficacy, safety and tolerability of three different dosage regimens of izokibep as compared to placebo.

“We believe that izokibep is well positioned to improve the life of patients with AS with its high potency and strong safety profile,” says Fredrik Frejd, CSO of Affibody. “In addition, the IL-17 biology offers ample scope for further development and commercialization. We look forward to exploring the drug’s use to address multiple indications.”

The announcement follows the 2020 initiation of a Phase 2 Psoriatic Arthritis study with izokibep (ABY-035). Inmagene and Affibody expect to file IND applications for izokibep in additional autoimmune diseases during the first part of 2021.

Photo of Fredrik Frejd: Affibody