FDA agrees on Abivax’s pediatric study plan to develop obefazimod for children with IBD
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The FDA has agreed on Abivax’s initial pediatric study plan for the development of obefazimod in children aged 2 to 17 years with inflammatory bowel disease, the company announced in a press release.
In October 2022, Abivax enrolled its first patient in ABTECT, a phase 3 program with obefazimod in adults with moderate to severe ulcerative colitis. With that program underway, Abivax initiated plans to develop obefazimod for children with IBD, starting with UC, the release stated.
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“The FDA agreement on the pediatric plan for obefazimod in IBD is an important step for Abivax to establish a wholistic and comprehensive development plan that includes an adult patient population as well as children and adolescents suffering from these diseases,” Hartmut J. Ehrlich, MD, CEO of Abivax, said in the release. “Ulcerative colitis or Crohn’s disease often occurs at a young age and may have a heavy impact on the quality of life and also on the general health and well-being of children and teenagers. With obefazimod, Abivax is committed to developing an efficient treatment option for these younger patients.”
According to the release, the ongoing ABTECT program plans to enroll 1,200 adults with UC from 36 counties and includes two induction trials, ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106), and a subsequent maintenance trial (ABX464-107). The program aims to confirm obefazimod’s potential to maintain and improve patient outcomes, in addition to its safety and tolerability profile, which has been observed in phase 2a and phase 2b clinical trials.