Merck reported positive topline results from the Phase 3 ATLAS-UC induction-only study evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting TL1A, in adults with moderately to severely active ulcerative colitis. The trial met its primary endpoint, showing clinical remission at week 12 based on the Modified Mayo Score, and also achieved key secondary endpoints. No safety concerns were identified, in line with earlier Phase 2 experience.
Tulisokibart is the first anti‑TL1A antibody to demonstrate clinical remission at 12 weeks in a Phase 3 study of moderately to severely active ulcerative colitis. The molecule was designed to help address immuno‑fibrosis, described as a key driver of chronic immune dysregulation and disease progression in inflammatory bowel disease and other immune‑mediated inflammatory conditions. Merck said the new induction data represent an important step for patients who continue to experience symptoms and do not achieve remission despite currently available therapies.
Results from ATLAS‑UC Study 2 will be presented together with outcomes from an ongoing induction and maintenance study (Study 1) at an upcoming scientific meeting and will be shared with regulators.
Tulisokibart is being studied across seven indications in what Merck describes as the broadest development program in the emerging anti‑TL1A class. Phase 3 trials include studies in ulcerative colitis and Crohn’s disease, while Phase 2 programs are underway in systemic sclerosis–associated interstitial lung disease, rheumatoid arthritis, psoriatic arthritis, radiographic axial spondyloarthritis and hidradenitis suppurativa.
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