Merck Expands Tulisokibart Clinical Development Program With Initiation of Phase 2b Trials in Three Additional Immune-Mediated Inflammatory Diseases

Core Insights - Merck has initiated three Phase 2b trials for tulisokibart, an investigational anti-TL1A monoclonal antibody, targeting immune-mediated inflammatory diseases [1][2] - The trials aim to enroll over 640 patients globally, expanding the clinical development program for tulisokibart to six diseases [1][2] - Tulisokibart is currently also being studied in two Phase 3 trials for ulcerative colitis and Crohn's disease, along with a Phase 2 study for systemic sclerosis-associated interstitial lung disease [2] Group 1: Clinical Trials and Development - Tulisokibart is being evaluated for its safety and efficacy in hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis [1][2] - The ongoing clinical trials reflect Merck's commitment to addressing immune-mediated inflammatory diseases [2][9] - The total number of diseases being investigated with tulisokibart has now reached six, indicating a broadening of its therapeutic potential [2] Group 2: Disease Overview - Hidradenitis suppurativa is a chronic inflammatory skin condition affecting 0.1% to 0.8% of the population [3] - Radiographic axial spondyloarthritis, also known as ankylosing spondylitis, affects approximately 0.1% to 1% of people globally [4] - Rheumatoid arthritis is estimated to affect 17.9 million people worldwide, representing a 13.2% increase since 1990 [5] Group 3: Mechanism and Target - Tulisokibart targets tumor necrosis factor (TNF)-like cytokine 1A (TL1A), which is associated with intestinal inflammation and fibrosis [6] - The antibody is believed to inhibit inflammatory pathways involved in inflammatory bowel disease, potentially altering disease progression [6][8]