BioMedTech Press Release

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

“The approval of our phase 1 study by the Japanese regulators is another important milestone as we are executing on our ABX464 global development strategy. Once the pharmacokinetics as well as safety and tolerability of ABX464 have been confirmed in the Japanese population, we will be able to subsequently expand our phase 3 clinical program to Japan. More and more people in industrialized countries are suffering from chronic inflammatory bowel diseases. Our objective is to make ABX464 broadly and globally available, including Japan where many patients are in need of new therapeutic options.” Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax.

  • 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