(Boursier.com) — The biotechnology company Abivaxannounced that the US regulatory agency, the FDA, has approved an initial pediatric study design (iPSP) for the clinical development of obefazimod in ulcerative colitis (UC) in children 2 to 17 years of age.
“FDA approval of obefazimod’s pediatric development plan for the treatment of inflammatory bowel disease is an important step for Abivax to establish a comprehensive and consistent approach that includes the adult patient population as well than children and adolescents with these conditions Ulcerative colitis and Crohn’s disease often start at a young age and can have a significant impact on the quality of life and overall health and well-being of children and adolescents. With obefazimod, Abivax is committed to providing an effective treatment option for these young patients,” said Professor Hartmut J. Ehrlich, CEO of Abivax.
Obefazimod is currently being tested in a Phase 3 clinical program in ulcerative colitis with the first patient enrolled in the United States on October 11, 2022. 1,200 patients with moderate to severe UC across 36 countries will be enrolled in this pivotal Phase 3 program which includes two induction studies and one maintenance study. This program aims to confirm the potential of obefazimod to maintain and improve clinical results over time, as well as its good safety profile, as already demonstrated in previously conducted phase 2a and phase 2b clinical trials. in patients with moderate to severe UC.
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