Merck has launched three Phase 2b clinical trials evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in patients with immune-mediated inflammatory diseases. The trials will assess the safety and efficacy of the novel therapy in hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis.
Expanding Clinical Development Program
The three new studies include MK-7240-12 (NCT06956235) for patients with moderate to severe hidradenitis suppurativa, MK-7240-013 (NCT07133633) for radiographic axial spondyloarthritis (also known as ankylosing spondylitis), and MK-7240-014 (NCT07176390) for rheumatoid arthritis. Global recruitment has begun, targeting enrollment of more than 640 patients across the three studies.
"The expansion of our tulisokibart clinical development program reflects Merck's ongoing commitment to addressing the burden of immune-mediated inflammatory diseases," said Dr. Aileen Pangan, vice president and head of immunology, global clinical development, Merck Research Laboratories. "We're excited to further evaluate the potential of tulisokibart as a treatment for patients across multiple diseases in rheumatology and dermatology."
Comprehensive Disease Portfolio
With these Phase 2b trials, tulisokibart is now being investigated in six diseases. Merck is currently conducting two Phase 3 studies evaluating the efficacy and safety of tulisokibart in inflammatory bowel disease: ATLAS-UC (NCT06052059) in ulcerative colitis and ARES-CD (NCT06430801) in Crohn's disease. The company is also running a Phase 2 study in systemic sclerosis-associated interstitial lung disease (NCT05270668).
Novel Mechanism of Action
Tulisokibart is an investigational humanized monoclonal antibody directed to TL1A, a novel target associated with both intestinal inflammation and fibrosis. The drug is thought to bind both soluble and membrane-bound human TL1A. Clinical studies suggest that tulisokibart may inhibit inflammatory pathways involved in inflammatory bowel disease and help reduce intestinal fibrosis, which may be important in altering disease progression.
Addressing Significant Disease Burden
The three new indications represent substantial unmet medical needs. Hidradenitis suppurativa is a chronic inflammatory skin condition affecting hair follicles, characterized by painful abscesses in areas such as the armpits, groin, buttocks and breasts, with prevalence estimates ranging from 0.1% to 0.8% of the population.
Radiographic axial spondyloarthritis involves chronic inflammation and pain of the spine and connecting joints, with damage visible on X-rays. The condition is thought to affect 0.1% to 1% of people worldwide. Rheumatoid arthritis, a chronic autoimmune condition causing joint inflammation, pain, swelling and stiffness, affects an estimated 17.9 million people globally, representing a 13.2% increase since 1990.
Strategic Focus on Immunology
Merck's research efforts are focused on investigating novel targets such as TL1A and CD30L and their potential role in immune-mediated inflammatory diseases. The company's scientists are applying their expertise to discover and develop therapies that aim to change treatment approaches for these conditions through innovative medicines and new modalities.
