Merck to Present Long-Term Data for Tulisokibart in IBD at UEG Week 2024

Merck, known as MSD outside the United States and Canada, has announced new data on the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting TNF-like cytokine 1A (TL1A). This data, pertaining to its use in treating ulcerative colitis (UC) and Crohn’s disease (CD), will be presented at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria.

The new long-term data comes from the open-label extension period of the Phase 2 ARTEMIS-UC and APOLLO-CD studies. These studies have shown that by week 50, patients who responded to the 12-week induction period generally maintained their treatment efficacy. Furthermore, the safety profile of tulisokibart during these extensions remained consistent with previously reported data.

Dr. Aileen Pangan, Vice President of Global Clinical Development at Merck Research Laboratories, noted the promise of tulisokibart in helping patients achieve long-term clinical remission for ulcerative colitis and Crohn’s disease. Dr. Pangan emphasized the persistent need for new treatment options, as many patients with inflammatory bowel disease (IBD) still struggle to reach their treatment goals despite the availability of existing therapies.

Merck has launched two Phase 3 clinical studies to further assess the efficacy and safety of tulisokibart in patients with UC and CD, named ATLAS-UC and ARES-CD respectively. These studies are pioneering efforts, as they are the first Phase 3 trials for an anti-TL1A antibody in the treatment of inflammatory bowel disease.

The Phase 2 ARTEMIS-UC study, which evaluated tulisokibart in patients with moderately to severely active ulcerative colitis, recently had its 12-week data published in the New England Journal of Medicine. These findings, initially presented at the 18th Congress of European Crohn’s and Colitis Organisation (ECCO) in 2023, demonstrated that tulisokibart was more effective than a placebo in inducing clinical remission in patients with severe UC. The publication also detailed additional data from a prespecified analysis of patients who had a positive response likelihood from cohorts 1 and 2.

Ulcerative colitis is a chronic condition that affects the large intestine and rectum, causing inflammation and ulcers. Symptoms include diarrhea, rectal bleeding, abdominal pain, rectal urgency, and weight loss. Some patients may also suffer complications such as strictures. This disease imposes a significant burden on over five million people globally.

Crohn’s disease is another chronic inflammatory condition that can affect any part of the gastrointestinal tract from the mouth to the anus. Symptoms include abdominal pain, diarrhea, and weight loss, and it can lead to complications such as fistulas and strictures. This disease impacts an estimated six to eight million people worldwide.

Tulisokibart is a humanized monoclonal antibody that targets TL1A, a cytokine associated with both intestinal inflammation and fibrosis. By binding to both soluble and membrane-bound TL1A, tulisokibart is believed to inhibit inflammatory pathways involved in IBD and potentially reduce intestinal fibrosis, which could alter disease progression. Merck is developing tulisokibart for the treatment of several immune-mediated inflammatory diseases, including ulcerative colitis, Crohn’s disease, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Merck has a long history of advancing medical treatments and is committed to using cutting-edge science to save and improve lives globally. The company continues to be at the forefront of research, delivering innovative health solutions for the prevention and treatment of various diseases in both humans and animals. Merck is dedicated to fostering a diverse and inclusive workforce and operating responsibly to ensure a sustainable and healthy future for all.