Teva Pharmaceutical Industries and Sanofi announced positive results from a phase 2b maintenance study of duvakitug, an investigational monoclonal antibody designed to target TL1A, a protein involved in inflammatory bowel disease. The long-term extension trial demonstrated durable clinical and endoscopic efficacy over a 44-week period in patients with ulcerative colitis and Crohn's disease who had previously responded to induction therapy.
The study achieved remission rates ranging from 47-58% in ulcerative colitis patients and 41-55% in Crohn's disease patients, with variations dependent on dosage levels. These findings indicate the drug maintained its therapeutic benefit over an extended treatment period, addressing a key clinical need in managing inflammatory bowel conditions that require sustained disease control.
Safety data from the trial remained consistent with previous studies, with no new adverse events identified during the maintenance phase. The results support the companies' advancement of duvakitug into ongoing phase 3 clinical development programs, representing progress toward potential regulatory approval for patients with moderate-to-severe inflammatory bowel disease.