(AOF) – The clinical phase 3 biotechnology company Abivax announces that it has enrolled the first patient in the United States in its global phase 3 program with Obefazimod in moderate to severe ulcerative colitis (UC). Nearly 1,200 UC patients across 36 countries and 600 investigation centers will be included in the ABTECT program which includes two induction studies and a single maintenance study. The 25 mg and 50 mg doses of obefazimod will be tested in patients naïve or refractory to advanced therapies.
The phase 3 program aims to confirm the excellent results of the open-label phase 2b maintenance study announced in April 2022, including the entire population of 217 patients who have completed one year of daily treatment with 50 mg of oral obefazimod or who prematurely discontinued the study. These data underscore the potential of obefazimod to maintain and improve clinical outcomes over time, as well as its good safety profile.
The program is progressing as planned and the first results of the two induction studies are expected by the end of 2024.