Merck & Co. has reported mixed clinical results for tulisokibart, its investigational anti-TL1A monoclonal antibody, with a Phase 2 study in systemic sclerosis-associated interstitial lung disease (SSc-ILD) failing to meet its primary endpoint while a separate Phase 2b trial in hidradenitis suppurativa (HS) achieved its primary and key secondary endpoints.
The company disclosed the findings in its second-quarter update, outlining both a setback and a positive development for the antibody across different disease areas. Merck said the outcome in SSc-ILD will lead to the discontinuation of that development program, while research in other indications continues.
Phase 2 Study in SSc-ILD Fails to Reach Primary Endpoint
According to Merck, the Phase 2 SSc-ILD trial did not achieve its primary endpoint. The study enrolled 154 patients and included three safety measures and one efficacy measure among its primary endpoints.
Following the result, the company decided to end development of tulisokibart in SSc-ILD. Merck stated that no new safety concerns were identified during the study but did not provide detailed efficacy data.
During an earnings call, Michael Kress, Ph.D., Merck’s senior vice president of developmental science and clinical supply, discussed the challenges associated with the disease area. He said the company would closely examine the study data, including the placebo arm, when the results are published.
Kress also said, “It’s a challenging and refractory disease.”
He further stated that the negative outcome in this specific patient population should not be viewed as disproving the broader immunofibrosis hypothesis being explored through TL1A-targeted therapies.
Mid-Stage Trial Produces Positive Results in HS
Merck reported more encouraging findings from a Phase 2b trial evaluating tulisokibart in HS. The company said the study met its primary endpoint as well as key secondary endpoints.
The trial enrolled 147 patients. Merck did not disclose detailed data from the study but said the results will be presented at a future medical meeting.
The HS success was reported alongside the SSc-ILD outcome, providing evidence of activity for the antibody in another indication within the company’s development program.
Development Program Continues Across Multiple Diseases
Tulisokibart became part of Merck’s pipeline through its 2023 acquisition of Prometheus Biosciences for $10.8 billion. The antibody, also known as MK-7240, has been a central component of the company’s immunology research efforts.
Earlier this year, Merck reported that a Phase 3 trial of tulisokibart in ulcerative colitis met its primary and key secondary endpoints. The company said patients achieved clinical remission in that study, although detailed results were not released.
Merck is continuing to evaluate the antibody in additional immune-mediated conditions. Ongoing clinical programs include studies in rheumatoid arthritis and radiographic axial spondyloarthritis. The company is also developing a subcutaneous formulation of tulisokibart for maintenance treatment.
Additional data are expected over the coming year, including Phase 3 maintenance results in ulcerative colitis and readouts from ongoing mid-stage studies in other indications.
Merck’s Tulisokibart has delivered mixed results across two Phase 2 clinical development programs. While Tulisokibart did not meet the primary endpoint in a study evaluating systemic sclerosis-associated interstitial lung disease (SSc-ILD), the therapy achieved its key goals in a separate hidradenitis suppurativa (HS) trial.
The contrasting results for Tulisokibart demonstrate how the performance of an investigational therapy can vary significantly across different diseases and patient populations.
Tulisokibart and the SSc-ILD Trial
In the SSc-ILD study, Tulisokibart failed to achieve the prespecified primary endpoint. SSc-ILD is a serious complication of systemic sclerosis in which inflammation and fibrosis can damage lung tissue and impair respiratory function.
The outcome means that Tulisokibart faces additional questions regarding its potential role in treating this difficult-to-manage condition.
The Tulisokibart program demonstrates both the opportunities and uncertainties associated with developing novel immunotherapies. Although the SSc-ILD failure represents a setback, the positive HS results may provide a path for continued development.
Additional clinical data will be important in determining whether Tulisokibart can advance toward later-stage trials and potentially become a treatment option for patients with inflammatory diseases.
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