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Abivax receives approval for ABX464 phase 1 study in Japanese subjects for subsequent inclusion of Japan into the global phase 3 program in ulcerative colitis

August 18, 2021

  • The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved a phase 1 clinical trial to confirm ABX464’s pharmacokinetic profile in Japanese subjects

  • This phase 1 study is required to include Japan in Abivax’s ABX464 global phase 3 program for the treatment of ulcerative colitis

  • As part of Abivax’s ABX464 late-stage development plan, three additional phase 1 studies are being conducted in healthy volunteers, all progressing according to plan

  • Abivax plans to initiate its global phase 3 clinical program in UC by year end

  • Following the announcement of the ABX464 phase 2b top-line data in UC, the full results will be communicated during the first half of September