Abivax establishes clinical, regulatory and manufacturing framework for ABX464 phase 3 program and potential commercialization in 2021
" We are putting significant efforts into ABX464 development and potential commercialization, to make ABX464 and its unique properties available to patients in need of novel treatment approaches worldwide ", Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax
• Pivotal ABX464 clinical trials ongoing or planned for three indications: Ulcerative colitis, Crohn’s disease and Covid-19
• Four phase 1 studies are being initiated to generate complementary data to support the late-stage development program of ABX464
• Discussions planned with regulatory agencies in Europe, the US and Japan to seek recommendations and agreement with the phase 3 development approach in ulcerative colitis and Crohn’s disease
• Development and upscaling of ABX464 manufacturing is ongoing to meet phase 3 needs and potential commercialization, in preparation of a possible positive Covid-19 trial outcome