Merck to Present New Long-Term Data for Tulisokibart (MK-7240), an Investigational Anti-TL1A Monoclonal Antibody, in Inflammatory Bowel Disease at UEG Week 2024
26 September 2024 - 12:45PM
Business Wire
Tulisokibart is now being evaluated in two
Phase 3 studies in ulcerative colitis and Crohn’s disease
12-week data from the Phase 2 ARTEMIS-UC
trial recently published in the New England Journal of
Medicine
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced that new data highlighting the long-term
efficacy and safety of tulisokibart (MK-7240), an investigational
humanized monoclonal antibody directed to a novel target, tumor
necrosis factor (TNF)-like cytokine 1A (TL1A), in ulcerative
colitis (UC) and Crohn’s disease (CD) will be presented at the
United European Gastroenterology (UEG) Week 2024 Congress in
Vienna, Austria.
Long-term efficacy and safety data for tulisokibart from the
open-label extension period of the Phase 2 ARTEMIS-UC and APOLLO-CD
studies will be featured in two oral presentations. In both
studies, at week 50, maintenance of treatment efficacy was
generally observed in 12-week induction responders. The observed
safety profile in the study extensions was consistent with
previously reported data. Key data presentation details:
- #OP078: Long-term efficacy and safety of tulisokibart in
patients with Crohn’s disease (CD): Results from the open-label
extension period of the Phase 2 APOLLO-CD study; October 14,
10:12-10:24 a.m. CEST
- #OP194: Long-term efficacy and safety of tulisokibart in
patients with ulcerative colitis (UC): Results from the open-label
extension period of the Phase 2 ARTEMIS-UC study; October 15,
11:54-12:06 p.m. CEST
“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,” said Dr. Aileen Pangan, vice president, global
clinical development, Merck Research Laboratories. “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.”
Merck has initiated two Phase 3 studies to evaluate the efficacy
and safety of tulisokibart in patients with UC (ATLAS-UC;
NCT06052059) and CD (ARES-CD; NCT06430801). These are the first Phase 3 clinical studies
for an anti-TL1A antibody in inflammatory bowel disease.
Additionally, results from ARTEMIS-UC, a Phase 2
proof-of-concept study evaluating the efficacy and safety of
tulisokibart in patients with moderately to severely active UC were
recently published in the New England Journal of Medicine. These
data were first presented at the 18th Congress of European Crohn’s
and Colitis Organisation (ECCO) in 2023. Findings published in the
New England Journal of Medicine show that after 12 weeks,
tulisokibart was more effective than placebo for inducing clinical
remission in patients with moderately to severely active UC. The
publication also includes additional data from a prespecified
analysis of patients with a positive test for likelihood of
response from cohorts 1 and 2.
About Ulcerative Colitis Ulcerative colitis (UC) is a
chronic disease of the large intestine that causes chronic
inflammation and ulcers in the lining of the large intestine and
rectum. Symptoms of UC include diarrhea, rectal bleeding, abdominal
pain, rectal urgency and weight loss, with some patients also
developing complications such as strictures. The severity of
symptoms places a substantial burden on the more than five million
people living with UC worldwide.
About Crohn’s Disease Crohn’s disease (CD) causes chronic
inflammation which can affect all parts of the gastrointestinal
tract from mouth to anus. Symptoms of CD include abdominal pain,
diarrhea with or without bleeding and weight loss. These symptoms,
along with complications such as fistulas and strictures, can cause
significant physical burden on the estimated six to eight million
people living with CD worldwide.
About Tulisokibart Tulisokibart is an investigational
humanized monoclonal antibody directed to a novel target, tumor
necrosis factor (TNF)-like cytokine 1A (TL1A), that is associated
with both intestinal inflammation and fibrosis. Tulisokibart 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 (IBD), and help
reduce intestinal fibrosis, which may be important in altering
disease progression in IBD. Merck is developing tulisokibart for
the treatment of immune-mediated inflammatory diseases including
ulcerative colitis, Crohn's disease and systemic
sclerosis-associated interstitial lung disease (SSc-ILD).
About Merck At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on X (formerly Twitter),
Facebook, Instagram, YouTube and LinkedIn.
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N.J., USA (the “company”) includes “forward-looking statements”
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