Merck Reveals New Long-Term Data For Tulisokibart At UEG Week 2024

Merck (NYSE: MRK), branded as MSD outside the US and Canada, has unveiled new findings on the long-term effectiveness and safety of tulisokibart (MK-7240), a novel humanized monoclonal antibody targeting the tumor necrosis factor (TNF)-like cytokine 1A (TL1A). These results, focusing on ulcerative colitis (UC) and Crohn’s disease (CD), will be showcased at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria.

The data from the Phase 2 ARTEMIS-UC and APOLLO-CD studies will be highlighted in two oral sessions. The long-term analysis from the open-label extension phases of these studies demonstrates sustained efficacy at week 50 for patients who initially responded to the 12-week induction therapy. The safety profile observed remained consistent with earlier reports. The key presentation details are as follows:

a.      OP078: Long-term efficacy and safety of tulisokibart in Crohn’s disease (CD), featuring results from the Phase 2 APOLLO-CD open-label extension; October 14, 10:12-10:24 a.m. CEST.

b.      OP194: Long-term efficacy and safety of tulisokibart in ulcerative colitis (UC), featuring results from the Phase 2 ARTEMIS-UC open-label extension; October 15, 11:54-12:06 p.m. CEST.

Merck has launched two pivotal Phase 3 trials to assess the effectiveness and safety of tulisokibart for treating ulcerative colitis (UC) and Crohn’s disease (CD). The ATLAS-UC (NCT06052059) and ARES-CD (NCT06430801) studies are the first Phase 3 investigations of an anti-TL1A antibody targeting inflammatory bowel disease. In addition, the Phase 2 ARTEMIS-UC study, which explored tulisokibart's impact on moderately to severely active UC, recently had its results published in the New England Journal of Medicine. 

These findings, originally presented at the 18th Congress of the European Crohn’s and Colitis Organisation (ECCO) in 2023, demonstrate that tulisokibart significantly outperformed placebo in inducing clinical remission after 12 weeks. The publication also includes supplementary data from a pre-specified analysis of patients showing a higher likelihood of response from initial study cohorts.

Dr. Aileen Pangan, vice president, global clinical development, Merck Research Laboratories, commented “Many patients with inflammatory bowel disease do not achieve their treatment goals despite available therapies. There is still a need for additional treatment options to enable patients to manage the challenging symptoms of ulcerative colitis and Crohn’s disease. We are encouraged by the new maintenance data for tulisokibart in ulcerative colitis and Crohn’s disease, which shows the potential of this novel approach to help patients achieve long-term clinical remission.