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15 Dec 2021
Admin
News Article

ACELYRIN INC. Affibody AB and Inmagene Biopharmaceuticals Announce Positive Interim Results from Global Phase 2 Trial of Izokibep in Patients with Psoriatic Arthritis

LOS ANGELES and SOLNA, Sweden and SHANGHAI, Dec. 14, 2021 /PRNewswire/ -- ACELYRIN, INC., Affibody AB, and Inmagene Biopharmaceuticals, today 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. (PRNewsfoto/ACELYRIN) The double-blind, placebo-controlled Phase 2 clinical trial, designed and conducted by Affibody AB, 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. "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," said Paul Peloso, MD, chief medical officer (CMO) of ACELYRIN. "We look forward to the trial continuation and presenting results in a future scientific forum." "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," commented Prof. Nikolai Brun, CMO of Affibody. "This is an important milestone to the overall advancement of izokibep," said Jean-Louis Saillot, MD, chief development officer of Inmagene. "We look forward to working closely with our partners ACELYRIN and Affibody to advance the global programs targeting multiple autoimmune indications." 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. 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. About izokibep Izokibep is a unique, antibody mimetic, interleukin-17A (IL-17A) inhibitor designed to overcome the limitations of monoclonal antibodies. With extraordinary potency and small molecular size, izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require IV administration to achieve. In addition, the small size of izokibep

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