BMS Submits Prospectus Highlighting Phase 3 Success of Deucravacitinib, a Selective TYK2 Allosteric Inhibitor, Demonstrating Superiority Over Common Oral Therapies in Moderate-to-Severe Plaque Psoriasis

Bristol-Myers Squibb (BMS) announced today that its oral, selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, met the primary endpoint in the second pivotal Phase 3 trial in patients with moderate-to-severe plaque psoriasis. Compared with placebo, it significantly increased the proportion of patients achieving PASI 75 (at least a 75% improvement in the Psoriasis Area and Severity Index) and clear or almost clear skin symptoms (sPGA score of 0 or 1).

The trial also met multiple key secondary endpoints, including demonstrating that deucravacitinib outperformed common oral PDE4 inhibitors on the primary endpoint at Week 16 post-treatment.

Psoriasis is a widely prevalent chronic, systemic, immune-mediated disease that severely impairs patients’ physical health, quality of life, and work productivity. It affects at least 100 million people worldwide and is characterized by distinct circular or oval plaques, typically covered with silvery-white scales. Psoriasis is associated with multiple comorbidities known to reduce life expectancy, including cardiovascular disease, metabolic syndrome, obesity, diabetes mellitus, inflammatory bowel disease, depression, and malignancies.

Deucravacitinib is a selective TYK2 inhibitor that suppresses the IL-12, IL-23, and type I interferon (IFN) pathways, which are implicated in the pathogenesis of psoriasis and other immune-mediated diseases. Deucravacitinib achieves selectivity by binding to the regulatory domain of TYK2, which is structurally distinct from JAK1, JAK2, and JAK3 kinases. At clinically relevant concentrations, deucravacitinib does not inhibit JAK1, JAK2, or JAK3 activity. Deucravacitinib is currently being investigated in a variety of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease.

The randomized, double-blind POETYK PSO-2 trial enrolled 1,020 patients to evaluate the efficacy and safety of deucravacitinib compared with placebo and a commonly used PDE4 inhibitor. Previously, deucravacitinib had met its primary endpoint in the Phase 3 POETYK PSO-1 clinical trial. Bristol-Myers Squibb stated that researchers will complete a comprehensive assessment of the POETYK PSO-2 data and share detailed results at future medical conferences.

“Deucravacitinib was designed as a selective TYK2 inhibitor that suppresses the IL-12, IL-23, and type I interferon pathways implicated in various immune-mediated diseases. The superior efficacy observed in patients with moderate-to-severe psoriasis, coupled with a well-tolerated safety profile, is consistent with the novel mechanism of action of deucravacitinib,” said Dr. Samit Hirawat, Chief Medical Officer of Bristol-Myers Squibb. “Deucravacitinib has the potential to become an important oral treatment option for patients with psoriasis. We look forward to discussing the results of the registrational POETYK PSO-1 and POETYK PSO-2 studies with regulatory authorities, with the aim of making this novel therapy available as soon as possible to people living with this serious disease.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast). Retrieved February 2, 2021, from https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Second-Pivotal-Phase-3-Psoriasis-Study-Showing-Superiority-of-Deucravacitinib-Compared-to-Placebo-and-Otezla-apremilast/default.aspx

▽Follow [WuXi AppTecDe】WeChat Official Account