First US patient enrolled in Abivax’s phase 3 trial of obefazimod for ulcerative colitis
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Abivax announced that the first U.S. patient has been enrolled in its global phase 3 clinical trial of its oral small-molecule inhibitor obefazimod for the treatment of moderate to severe ulcerative colitis.
The trial will include two induction studies – ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) – and a subsequent ABTECT maintenance trial (ABX464-107) that will investigate 25 mg and 50 mg doses of obefazimod for the treatment of patients with UC who are either naïve to or previously failed advanced therapies.
“As the principal investigator in the U.S., I am excited about the first patient included in the obefazimod phase 3 program for the treatment of moderate to severe UC,” Bruce E. Sands, MD, MS, chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai, said in a press release. “Obefazimod has already shown very promising results in the precedent phase 2a and phase 2b induction and maintenance trials.”
He added: “As a practicing gastroenterologist, I am confronted every day with the high unmet medical need for safe therapies that have long-term efficacy and convenient administration for patients with ulcerative colitis. I am optimistic that the ABTECT program will confirm obefazimod’s potential to address these medical needs.”
The phase 3 ABTECT program is intended to confirm results from its phase 2b open-label maintenance study, which reported clinical remission in 55.3% of UC patients (n=217) following 48 weeks of once-daily oral 50 mg obefazimod, as well as a good safety and tolerability profile.
Abivax stated that the investigators plan to enroll 1,200 patients across 36 countries and 600 study centers, with top-line results of the two induction studies expected to be available at the end of 2024.
“We are very happy that our pivotal global phase 3 program has successfully started in the US with the enrollment of the first patient,” Hartmut J. Ehrlich, MD, CEO of Abivax, said in the release. “Given our previous experience, we expect a vast majority of the patients completing the induction trials to enroll into the subsequent maintenance study and to reproduce the outstanding long-term phase 2a and 2b safety and efficacy results with obefazimod. Once the required data are available, we will proceed swiftly to request market authorizations in the US and in Europe, also supported by the unique mechanism of action of obefazimod and its easy, once-daily oral administration.”
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