Merck Scores Key Phase 3 Win For Novel Ulcerative Colitis Therapy

Merck & Co Inc. (NYSE:MRK) on Monday said its investigational therapy tulisokibart achieved the primary endpoint in a Phase 3 study in moderately to severely active ulcerative colitis (UC), marking what the company described as the first positive Phase 3 induction results for an anti-TL1A biologic.

Positive Data For Tulisokibart In Ulcerative Colitis

The company announced that the Phase 3 ATLAS-UC induction-only study, also known as Study 2, met its primary endpoint of clinical remission at week 12 based on the Modified Mayo Score. The trial also achieved key secondary endpoints.

Merck added that the safety profile observed in the study was consistent with previously reported Phase 2 findings, with no new safety concerns identified.

Positive Data Marks Milestone For Anti-TL1A Class

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said the findings represent an important advance for patients with moderate-to-severe ulcerative colitis who continue to experience symptoms despite currently available treatments.

Barr said the results reinforce the potential of targeting tumor necrosis factor-like cytokine 1A, or TL1A, as a novel approach designed to address immuno-fibrosis, which he described as a major contributor to chronic immune dysregulation and disease progression in ulcerative colitis.

Broad Development Program Continues Across Multiple Diseases

According to Merck, tulisokibart currently has the broadest development program among investigational anti-TL1A therapies, spanning seven disease indications.

In addition to Phase 3 programs in ulcerative colitis and Crohn’s disease, the company is evaluating the therapy in Phase 2 studies across several immune-mediated conditions, including systemic sclerosis-associated interstitial lung disease, rheumatoid arthritis, psoriatic arthritis, radiographic axial spondyloarthritis, and hidradenitis suppurativa.

MRK Stock Price Activity: Merck & Co shares were up 1.41% at $115.47 at the time of publication on Monday, according to Benzinga Pro data.

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