BioMedTech Press Release

Abivax provides an update on the ABX464 clinical data and development strategy in ulcerative colitis

  • Excellent once-daily oral ABX464 efficacy and safety data in the phase 2b clinical trial in ulcerative colitis (UC) patients, previously reported at 8-weeks, are further improved at 16-weeks

  • Additional analyses (incl. miR-124 levels, histopathology, quality of life, etc.) underpin the potential of ABX464 to become a safe short- and long-term efficient treatment option in UC

  • Novel and highly differentiated mechanism of action of ABX464 confirmed, showing specific upregulation of a single microRNA, miR-124

  • Additional long-term data of the ABX464 phase 2a open-label maintenance study in UC confirm the good safety and potent efficacy of ABX464 after 3 years of continuous chronic treatment

  • For the launch of its phase 3 program in UC, Abivax is getting ready for the mandatory consultations with the regulatory authorities, starting with feedback from the US regulatory agency (FDA) expected by year end

  • Abivax’ late breaking abstract on the phase 2b data in UC was selected for oral presenta-tion during UEG Week Virtual 2021 (Monday, October 4). The data will be presented by the study’s principal investigator, Prof. Séverine Vermeire, M.D., Ph.D.

  • Also, on the same day at UEG Week Virtual 2021, Abivax will host a Live Industry Symposium with presentations by key opinion leaders Prof. Bruce Sands, M.D., M.S. and Prof. William Sandborn, M.D.