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Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints
Prnewswire· 2025-08-25 05:46
Core Insights - Akeso Inc. announced positive results from its Phase 3 clinical trial of gumokimab (AK111) for active ankylosing spondylitis (AS), meeting all primary efficacy endpoints and key secondary endpoints [1][2] - Gumokimab has shown rapid and effective alleviation of AS symptoms, improving disease activity, physical function, and quality of life for approximately 4 million AS patients in China [2] - Akeso's manfidokimab (AK120) also achieved positive outcomes in its Phase 3 trial for moderate-to-severe atopic dermatitis (AD), meeting all primary and key secondary endpoints [3][4] Company Developments - Akeso plans to file New Drug Applications (NDA) for both gumokimab and manfidokimab, marking significant milestones in the company's expanding autoimmune pipeline [4] - The successful market launches of ebronucimab and ebdarokimab, along with recent positive Phase 3 studies, are expected to drive commercial growth for Akeso's non-oncology franchise [5] - Akeso's robust pipeline includes over 50 innovative assets, with 24 candidates in clinical trials and 7 new drugs already commercially available [9]