Affibody and Inmagene announce IND Clearance for izokibep (ABY-035) for the treatment of Non-infectious Non-anterior Uveitis
March 9, 2021
Partners will continue to file INDs in additional applications in autoimmune diseases during 2021
San Diego, U.S., Shanghai, China, and Solna, Sweden, March 9, 2021. Affibody AB (“Affibody”) and Inmagene Biopharmaceuticals (“Inmagene”) today announced that the U.S. 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”), an orphan disease with significant unmet medical need. 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.
“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” said Quan Dong Nguyen, MD, MSc, 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.”
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”, commented 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.
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
The company operates a focused experimental medicine model and currently has two clinical stage programs. The first is izokibep that targets autoimmune diseases. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.
Affibody AB is a holding of Patricia Industries.
Further information can be found at: www.affibody.com