Bristol Myers Squibb’s Oral TYK2 Inhibitor Deucravacitinib Fails Phase 2 Proof-of-Concept Study in Ulcerative Colitis

Ulcerative colitis (UC, Image source: healthjade.com)

October 13, 2021 /BioonBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that evaluating the novel anti-inflammatory drug deucravacitinib (BMS-986165) versus placebo for the treatment of moderate to severe ulcerative colitis (UC)The Phase 2 LATTICE-UC study did not meet the primary endpoint (clinical remission at Week 12) or the secondary efficacy endpoints.In this study, the safety profile of deucravacitinib was consistent with that previously reported in studies of psoriasis and psoriatic arthritis, with no new safety signals observed.

The company will complete a comprehensive review of the LATTICE-UC study data and will continue to evaluate the potential of deucravitinib in the treatment of UC in the Phase 2 IM011-127 trial (including a higher dose).

Samit Hirawat, M.D., Chief Medical Officer of Bristol-Myers Squibb, stated: “Deucravacitinib has been proven to be a highly effective, first-in-class oral selective TYK2 inhibitor for the treatment of psoriasis, and we are conducting Phase 3 trials to explore the potential of deucravacitinib in treating psoriatic arthritis. Although we did not achieve proof of concept in the Phase 2 LATTICE-UC study, we remain committed to advancing the clinical programs of deucravacitinib for inflammatory bowel disease (including UC and Crohn’s disease [CD]), as well as psoriatic arthritis, lupus, and other immune-mediated diseases. Bristol-Myers Squibb thanks the patients and participants in the LATTICE-UC”Clinical Trialresearchers.”

Chemical structure of deucravacitinib (Image source: genome.jp)

Deucravacitinib is a novel oral selective TYK2 inhibitor developed by Bristol-Myers Squibb, featuring a unique mechanism of action distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates the signaling of IL-23, IL-12, and type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Currently, deucravacitinib is being evaluated for the treatment of a wide range of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease. Pharmaceutical market research firm EvaluatePharma released a report earlier this year predicting that,Sales of deucravacitinib will reach $2.21 billion in 2026.

In April this year, Bristol-Myers Squibb at the 2021 American Academy of Dermatology virtualConferenceEvaluation data were presented at the AAD VMX (Virtual Meeting Experience).Eucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasisthe positive results from the two pivotal Phase 3 studies (POETYK PSO-1, POETYK PSO-2).

Results showed that,Both studies met the co-primary and secondary endpoints.: Confirmed that deucravacitinib (6 mg, once daily) demonstrated significant efficacy and superiority compared with placebo and Otezla (apremilast, 30 mg, twice daily), including a significantly higher proportion of patients achieving at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) and a Static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at Week 16 compared with placebo and Otezla, and a higher proportion of patients achieving PASI 75 and sPGA 0/1 at Week 24 compared with Otezla, with responses maintained through Week 52. In this study, deucravacitinib exhibited a favorable safety and tolerability profile. (Bioon.com)

Original Source:Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis