Bristol Myers Squibb Announces Positive Top-Line Results from First Pivotal Phase 3 Trial of Oral TYK2 Inhibitor Deucravacitinib in Moderate-to-Severe Plaque Psoriasis

Bristol-Myers Squibb (BMS) announced today that its innovative oral TYK2 inhibitor, deucravacitinib (BMS-986165), met both primary endpoints in the first pivotal Phase 3 clinical trial evaluating its efficacy in patients with moderate-to-severe plaque psoriasis. The drug demonstrated superiority compared to both the placebo group and the active control group. This marks the first innovative oral selective TYK2 inhibitor to show positive efficacy in a Phase 3 clinical trial.

Psoriasis is a widely prevalent chronic, systemic, immune-mediated disease affecting at least 100 million people worldwide. It significantly impairs patients’ physical health, quality of life, and work productivity. Up to 90% of patients with psoriasis have psoriasis vulgaris or plaque psoriasis, characterized by distinct round or oval plaques typically covered with silvery-white scales. Psoriasis can cause significant psychological distress, and associated pain may lead to functional disability and reduced quality of life. It is also associated with various comorbidities known to reduce life expectancy, including cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, depression, and malignancies.

TYK2 is a member of the JAK family of proteins and an intracellular signaling kinase that mediates signal transduction for IL-23, IL-12, and type I interferons (IFN). It plays a crucial role in transmitting inflammatory and immune response signals. Deucravacitinib is a novel oral selective TYK2 inhibitor with a unique mechanism of action; it inhibits TYK2 activity by binding to its regulatory domain. Currently, it is being evaluated in multiple clinical trials for the treatment of various immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease.

▲Deucravacitinib (BMS-986165) has a unique mechanism of action (Image source: Bristol-Myers Squibb official website)

In this randomized, double-blind, placebo- and active-controlled Phase 3 clinical trial named POETYK PSO-1, a total of 666 patients with moderate-to-severe plaque psoriasis were randomly assigned to receive deucravacitinib, placebo, or an approved oral PDE4 inhibitor. The trial results demonstrated that a greater proportion of patients treated with deucravacitinib achieved the PASI 75 response criterion (indicating at least a 75% improvement in the Psoriasis Area and Severity Index) compared to those in the placebo and active control groups. After 16 weeks of treatment, a higher number of patients in the deucravacitinib group achieved complete or almost complete clearance of skin symptoms.

References:

[1] Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla® (apremilast) in Pivotal Phase 3 Psoriasis Study. Retrieved November 3, 2020, from https://www.businesswire.com/news/home/20201103005189/en

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