Merck has reported positive results from the ATLAS-UC induction-only study evaluating tulisokibart in patients with moderately to severely active ulcerative colitis (UC).
According to the company, tulisokibart met the study’s primary endpoint by demonstrating a benefit over placebo in achieving clinical remission at week 12, as measured by the Modified Mayo Score. Merck also said the drug met key secondary endpoints in the study.
At 12 weeks, patients who received tulisokibart achieved clinical remission of ulcerative colitis symptoms. The company further reported improvements in the condition of the colon and reduced inflammation in tissue samples after 12 weeks. Merck said no safety concerns were identified during the study.
Merck stated that the result represents the first time an anti-TL1A antibody has delivered a positive result on clinical remission after 12 weeks in this patient population. The company did not provide detailed efficacy data, including specific remission rates or other quantitative findings from the trial.
The drug is designed to block TL1A, a protein involved in immune activity and scar-like tissue buildup. Tulisokibart was acquired through Merck’s $11 billion purchase of Prometheus Biosciences in 2023 and is being studied in multiple immune-mediated inflammatory diseases.
Merck said it plans to present detailed findings from the study, along with results from an ongoing induction and maintenance study, at an upcoming scientific congress. The company also said the data will be shared with regulators.
Ulcerative colitis is a chronic bowel disease that causes long-lasting inflammation and ulcers in the innermost lining of the large intestine and rectum. The treatment landscape for the disease includes medicines with different mechanisms of action. Current treatments include Takeda’s Entyvio, AbbVie’s Skyrizi and Rinvoq, Johnson & Johnson’s Tremfya, as well as older medicines such as Humira and Stelara, which are facing biosimilar competition.
Tulisokibart is part of a newer class of immunology medicines targeting TL1A. Other companies with candidates in the area include Spyre Therapeutics, Bionyra, and partners Sanofi and Teva. Merck’s candidate is also being evaluated beyond ulcerative colitis as the company explores its potential use across a broader range of immune-mediated inflammatory conditions.
Analysts noted that the limited information released so far makes it difficult to compare the drug with existing treatments. Citi analyst Geoff Meacham said, “The lack of data, for now, limits competitive read-through” with rival treatments.
Meacham also noted that Merck did not disclose how many patients achieved remission, how different doses performed, how the drug compared with placebo, or how it performed in specific patient groups. In a note to clients, Citi analysts said it would be necessary to review the full data to determine whether the drug can demonstrate differentiation through maintenance results, endoscopic outcomes, histologic-endoscopic measures, or biomarker findings. The analysts also said that until the full dataset becomes available, it is reasonable to expect the drug to take a back seat to current IL-23 and JAK therapies.
RBC Capital Markets analyst Trung Huynh said the results represent the first positive late-stage data for an anti-TL1A drug and give Merck an early lead in the drug class. Huynh described the class as a “compelling therapeutic option” for inflammatory bowel disease.
Beyond ulcerative colitis, Merck is testing tulisokibart in Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and other immune-mediated inflammatory diseases. The company said the drug is currently being tested across seven diseases.
Merck has announced positive Phase 3 clinical trial results for Tulisokibart in patients with ulcerative colitis, marking a significant achievement for the company’s growing immunology portfolio. The encouraging findings demonstrate Merck’s continued commitment to developing innovative therapies for chronic inflammatory diseases that affect millions of people worldwide.
Merck Achieves Key Phase 3 Milestone
The successful trial outcome represents an important milestone for Merck as it advances Tulisokibart through late-stage clinical development. Positive Phase 3 data can play a critical role in supporting future regulatory submissions and bringing new treatment options closer to patients.
The results also reinforce confidence in the scientific approach that Merck has taken to address complex immune-mediated conditions.
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