Abivax SA has announced that its Phase 3 ABTECT trial, which is evaluating obefazimod for the treatment of moderately to severely active ulcerative colitis (UC), has reached a key enrollment milestone with over 600 patients now participating. This achievement keeps the trial on schedule for full enrollment by early Q1 2025.
The ABTECT trial is a global, pivotal Phase 3 program designed to assess the efficacy and safety of obefazimod in patients with UC. The trial's progress is a significant step forward in addressing the unmet needs of individuals suffering from this chronic inflammatory bowel disease, which affects millions worldwide.
Obefazimod: A Novel Approach to UC Treatment
Obefazimod (ABX464) is an orally administered small molecule that has shown potential in enhancing the expression of microRNA-124 (miR-124). This microRNA plays a crucial role in regulating inflammatory responses within the body. By increasing miR-124 expression, obefazimod aims to stabilize the immune response and reduce inflammation in the gut, offering a novel approach to treating UC.
Positive data from Phase 2 clinical trials of obefazimod in UC patients led to the initiation of the ABTECT program. The first patients were enrolled in the United States in October 2022. Furthermore, Abivax plans to initiate a Phase 2b clinical trial of obefazimod in Crohn's disease in Q3 2024, expanding the drug's potential application to other inflammatory bowel diseases.
Trial Design and Patient Population
The ABTECT trial is enrolling patients with moderately to severely active UC. The baseline characteristics of the enrolled participants are reportedly consistent with those observed in the Phase 2b trial, suggesting a similar patient population. This consistency is important for the reliability and generalizability of the trial results.
Ulcerative Colitis: An Unmet Medical Need
Ulcerative colitis is a chronic inflammatory condition affecting the large intestine. Symptoms include persistent diarrhea, abdominal pain, and rectal bleeding, significantly impacting patients' quality of life. Current treatments often involve anti-inflammatory drugs and immunosuppressants, which can have significant side effects. There remains a substantial unmet need for more effective and safer therapies for UC.
Abivax is a clinical-stage biotechnology company focused on developing therapies that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. With its lead drug candidate, obefazimod, in Phase 3 clinical trials, Abivax is striving to provide innovative solutions for patients with ulcerative colitis and other inflammatory conditions.
