San Diego, U.S., Shanghai, China, and Solna, Sweden, February 10, 2021 — Inmagene Biopharmaceuticals (“Inmagene”) and Affibody AB (“Affibody”) today announced that the U.S. FDA has cleared izokibep (IMG-020) 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,” said Dr. 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.”
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”, commented 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.”
Today’s announcement follows the 2020 initiation of a Phase 2 Psoriatic Arthritis study with izokibep (IMG-020). Inmagene and Affibody expect to file IND applications for izokibep in additional autoimmune diseases during the first part of 2021.
About Inmagene Biopharmaceuticals
Inmagene, with wholly owned subsidiaries in San Diego, Shanghai, and Hangzhou, is a leading biotech company focused on immunology-related therapeutic areas. Believing in “borderless innovation”, the Inmagene team integrates the most efficient resources worldwide to develop drugs for worldwide patients. It also in-licenses products for the Asia markets and, together with its partners, carries out global development activities, including multi-regional clinical trials.
Inmagene is building a strong pipeline with over 10 drug candidates for immunological diseases. IMG-020, Inmagene’s most advanced drug candidate, is in global clinical trials for multiple indications. The company has formed strategic partnerships with HUTCHMED (Nasdaq/AIM: HCM) and Affibody AB to develop and commercialize highly innovative drug candidates. In addition, Inmagene is developing 9 new molecules with global intellectual property rights from discovery stages.