Merck: Tulisokibart meets primary and key secondary endpoints in Phase 3 ATLAS‑UC induction study
- ATLAS‑UC Study 2 met its primary endpoint of clinical remission per Modified Mayo Score at week 12.
- Key secondary endpoints at week 12—endoscopic improvement, clinical response per MMS and histologic‑endoscopic mucosal improvement—were achieved.
- No safety concerns were identified, consistent with previously reported Phase 2 studies.
- Tulisokibart is the first anti‑TL1A monoclonal antibody to demonstrate Phase 3 clinical remission in UC and is being evaluated across seven indications, including Crohn’s disease.
Topline results
Merck reported that the Phase 3 ATLAS‑UC induction‑only study (Study 2) of tulisokibart (MK‑7240), an anti‑TL1A humanized monoclonal antibody, met its primary endpoint of clinical remission per the Modified Mayo Score (MMS) at week 12 and also met key secondary endpoints.
Study design
ATLAS‑UC is a Phase 3, randomized, double‑blind, placebo‑controlled program in adults with moderately to severely active ulcerative colitis. Study 2 randomized participants to a high‑dose IV, a low‑dose IV of tulisokibart or IV placebo to assess induction efficacy at week 12. Key secondary endpoints included endoscopic improvement, clinical response per MMS and histologic‑endoscopic mucosal improvement.
Safety
Merck stated no safety concerns were identified in Study 2, consistent with prior Phase 2 data.
Clinical development and next steps
Results from Study 2 will be presented alongside results from the ongoing induction and maintenance Study 1 at an upcoming scientific congress and will be submitted to regulatory authorities. Tulisokibart is being evaluated across seven disease indications, including a Phase 3 program in Crohn’s disease (ARES‑CD) and Phase 2 studies in several immune‑mediated conditions. The molecule targets TL1A and is being developed to address inflammation and immuno‑fibrosis in UC and other diseases.
Source: Merck
