Bristol Myers Squibb today announced the Phase 2 LATTICE-UC study evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at Week 12, nor secondary efficacy endpoints. The safety profile of deucravacitinib was consistent with previously reported studies in psoriasis and psoriatic arthritis, and no new safety signals were observed.
“Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.”
The company will complete a full review of the data from LATTICE-UC and the potential of deucravacitinib in UC continues to be evaluated in IM011-127, a second Phase 2 trial that also includes a higher dose.
Bristol Myers Squibb continues to expect greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.
LATTICE-UC (IM011-024) is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of deucravacitinib in participants with moderate to severe ulcerative colitis (UC). The primary endpoint of the trial is clinical remission (using the modified Mayo score) at Week 12. Secondary endpoints include clinical response (using the modified Mayo score), endoscopic response, and histological improvement at Week 12. More information can be found on www.clinicaltrials.gov (NCT03934216).
IM011-127 is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety, efficacy and biomarker response of deucravacitinib in participants with moderate to severe ulcerative colitis (UC). The primary endpoints of the trial are clinical response and safety and tolerability at Week 12. More information can be found on www.clinicaltrials.gov (NCT04613518).
Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action and is the first and only selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.
Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for use in any country.
About Ulcerative Colitis
Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), is characterized by an irregular, chronic immune response that creates inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school. Many patients have an inadequate response or do not respond at all to currently available therapies.It is estimated that approximately 14.9 million people worldwide are living with IBD.
Source: Bristol-Myres Squibb
Date: Oct 7, 2021
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