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Affibody and Inmagene announce IND Clearance

The US FDA has cleared the novel interleukin-17 (IL-17) blocker izokibep (ABY-035) to proceed to Phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.

“Uveitis is one of the leading causes of blindness worldwide. Through the years, we have learned much about the role of IL-17 in the pathogenesis of non-infectious uveitis; thus, we are very excited about the LINNAEA study to investigate a novel mechanism of blocking IL-17,” says Quan Dong Nguyen, FARVO, Principal Coordinating Investigator of the LINNAEA Study, and Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, USA. “We have designed the study to evaluate the role of izokibep as a first-line therapeutic option for active non-infectious uveitis as well as a steroid-sparing immunomodulatory agent.”

A one-year phase 2 trial

The partners are jointly developing izokibep to treat multiple autoimmune diseases, and Affibody has taken the responsibility to manage the global clinical trials for Uveitis. The study is a one-year phase 2 trial in approximately 110 patients with active Uveitis. The trial will evaluate the efficacy, safety and tolerability of izokibep as compared to standard of care.

“The LINNAEA Study in uveitis patients is an example of a modern trial design that has been developed in close collaboration with leading ophthalmologists,” says David Bejker, CEO of Affibody. “It also represents our commitment to bring potential best-in-class first-in-indication medicines to patients with seriously debilitating diseases.”

Inmagene and Affibody expect to file IND applications for izokibep in additional autoimmune diseases during 2021.

Photo of David Bejker: Affibody