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MRK Expands Tulisokibart Program in Three New Inflammatory Diseases
ZACKS· 2025-10-07 17:01
Core Insights - Merck has initiated three phase IIb studies for its investigational TL1A inhibitor, tulisokibart (MK-7240), targeting three immune-mediated inflammatory diseases [1][2][7] - Tulisokibart is now being studied across six immune-mediated inflammatory diseases, expanding its clinical evaluation [3][7] - Merck's phase III pipeline has nearly tripled since 2021, enhancing its long-term growth potential with around 20 new vaccines and drugs expected to launch in the coming years [5][8][9] Study Details - The three new phase IIb studies focus on moderate-to-severe hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis [2][3] - Tulisokibart is also being evaluated in phase III studies for ulcerative colitis and Crohn's disease, along with another phase II study for systemic sclerosis-associated interstitial lung disease [3] Financial Performance - Year-to-date, Merck's shares have declined by 10.7%, contrasting with an 8.5% increase in the industry [4] - The recent acquisition of Verona Pharma for approximately $10 billion is expected to strengthen Merck's cardio-pulmonary pipeline [10] Pipeline and Product Development - Merck's pipeline includes promising candidates such as enlicitide decanoate/MK-0616 for hypercholesterolemia, bomedemstat/MK-3543 for essential thrombocythemia, and nemtabrutinib/MK-1026 for hematological malignancies [9] - The company is positioned to launch multiple new products, many of which have blockbuster potential [5][8]
Merck Expands Tulisokibart Clinical Development Program With Initiation of Phase 2b Trials in Three Additional Immune-Mediated Inflammatory Diseases
Businesswire· 2025-10-06 10:45
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]