Merck’s Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score (MMS) at week 12, as well as key secondary endpoints. Consistent with previously reported Phase 2 studies, no safety concerns were identified. “These positive Phase 3 induction results for tulisokibart are the first for an anti-TL1A biologic. They represent an important step forward for patients with moderately to severely active ulcerative colitis who – despite available treatments – continue to experience symptoms, and do not achieve clinical remission,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These results reinforce the potential of this novel approach designed to help address immuno-fibrosis, a key driver of chronic immune dysregulation and disease progression in ulcerative colitis.” Results from the ATLAS-UC Study 2 will be presented with the results from the ongoing induction and maintenance study (Study 1) at an upcoming scientific congress and will be shared with regulatory authorities. Tulisokibart has the broadest development program in the novel anti-TL1A class and is currently being evaluated in seven disease indications. Phase 3 studies include ATLAS-UC (NCT06052059) in UC and ARES-CD (NCT06430801) in Crohn’s disease (CD). Phase 2 studies are evaluating tulisokibart in systemic sclerosis-associated interstitial lung disease (SSc-ILD) (NCT05270668), rheumatoid arthritis (RA) (NCT07176390), psoriatic arthritis (PsA) (NCT07486960), radiographic axial spondyloarthritis (r-axSpA) (NCT07133633) and hidradenitis suppurativa (HS) (NCT06956235). For an overview of Merck’s clinical development program in immunology, please click here. About ATLAS-UC ATLAS-UC (NCT06052059) is a Phase 3, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of tulisokibart in adults with moderately to severely active ulcerative colitis (UC). The program consists of two in...

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