A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
Latest Information Update: 19 Jul 2024
At a glance
- Drugs Obefazimod (Primary)
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms ABTECT-2
- Sponsors Abivax
- 15 Jul 2024 According to an Abivax media release, based on the timelines and by assuming favorable results from the ABTECT trial program , the Company anticipates being in position to submit an NDA to the FDA in late H1 2026, seeking approval of obefazimod for the treatment of moderately to severely active UC.
- 15 Jul 2024 According to an Abivax media release, expected top-line induction data read-out after eight weeks of treatment in Early Q2 2025.
- 15 Jul 2024 According to an Abivax media release, anticipated enrollment completion of ABTECT program in early Q1 2025 and top-line results anticipated in early Q2 2025.