Merck has announced positive topline results from the phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanised 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.

Dr. Eliav Barr, Senior Vice President (SVP), Head of Global Clinical Development and Chief Medical Officer (CMO), Merck Research Laboratories, said, “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. 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 7 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).