Last updated: December 30, 2024
Introduction to BMS-986165 (Deucravacitinib)
BMS-986165, also known as deucravacitinib, is a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor developed by Bristol Myers Squibb. This drug candidate is being evaluated for the treatment of various immune-mediated diseases, with a primary focus on moderate to severe plaque psoriasis.
Mechanism of Action
Deucravacitinib operates through a unique mechanism of action, distinct from other kinase inhibitors. It selectively inhibits TYK2, 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. This selectivity is crucial in reducing the risk of adverse effects associated with broader kinase inhibition[5].
Clinical Trials and Efficacy
The development of deucravacitinib has been supported by several pivotal Phase 3 clinical trials, including the POETYK PSO-1 trial. This trial demonstrated the superiority of deucravacitinib over placebo and Otezla (apremilast) in achieving key endpoints such as Psoriasis Area and Severity Index (PASI) 75 and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment[5].
POETYK PSO Clinical Trial Program
The POETYK PSO clinical trial program includes multiple Phase 3 studies:
- POETYK PSO-1: The first global Phase 3 study, which showed deucravacitinib's efficacy and safety compared to placebo and Otezla.
- POETYK PSO-2, PSO-3, and PSO-4: Additional Phase 3 studies evaluating deucravacitinib in different patient populations.
- POETYK PSO-LTE: A long-term study focusing on the safety and efficacy of deucravacitinib in patients with moderate to severe plaque psoriasis[5].
Regulatory Updates
As of 2021, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, with a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. The European Medicines Agency (EMA) also validated the Marketing Authorization Application (MAA) for the same indication. Additionally, Japan's Ministry of Health, Labour and Welfare accepted the NDA for deucravacitinib for treating various forms of psoriasis[1].
Safety and Long-Term Efficacy
A long-term study (NCT04036435) is currently in progress to characterize the long-term safety and efficacy of deucravacitinib in patients who have previously participated in applicable Phase 3 psoriasis studies. This study aims to provide comprehensive data on the sustained safety and efficacy profile of deucravacitinib over an extended period[3].
Market Projection
Growing Psoriasis Market
The psoriasis market is anticipated to show significant growth from 2024 to 2034, driven by increasing prevalence, recent drug approvals, and the anticipated launch of novel therapies. DelveInsight's analysts estimate that the psoriasis market size in the US was USD 17 billion in 2022, and this figure is expected to rise due to various factors, including enriched investment in disease awareness and direct-to-consumer advertising[2].
Competitive Landscape
Deucravacitinib is poised to enter a competitive market that includes other recently approved treatments such as BIMZELX (bimekizumab-bkzx), the first and only IL-17A and IL-17F inhibitor approved for moderate to severe plaque psoriasis. However, deucravacitinib's unique mechanism of action and its potential for a better safety profile, particularly compared to JAK inhibitors, present a significant opportunity in the psoriasis therapeutic space[2].
Market Opportunities
The psoriasis market offers lucrative opportunities for pharmaceutical companies, especially for drugs with improved clinical profiles. The limited treatment options available for relapsed or refractory patients and the safety concerns associated with existing therapies like JAK inhibitors create a niche for deucravacitinib to fill. The drug's potential in treating other immune-mediated diseases such as psoriatic arthritis, lupus, and inflammatory bowel disease further expands its market potential[2][5].
Key Takeaways
- Clinical Efficacy: Deucravacitinib has demonstrated superiority over placebo and Otezla in Phase 3 trials for moderate to severe plaque psoriasis.
- Regulatory Progress: The FDA and EMA have accepted applications for deucravacitinib, with a PDUFA goal date set for September 2022.
- Safety Profile: Ongoing long-term studies aim to establish the sustained safety and efficacy of deucravacitinib.
- Market Potential: The psoriasis market is expected to grow significantly, driven by increasing prevalence and the need for safer, more effective treatments.
- Competitive Advantage: Deucravacitinib's unique mechanism of action and potential for a better safety profile position it favorably in the competitive psoriasis market.
FAQs
What is the mechanism of action of deucravacitinib?
Deucravacitinib selectively inhibits tyrosine kinase 2 (TYK2), an intracellular signaling kinase involved in the signaling of IL-23, IL-12, and Type I IFN, which are naturally occurring cytokines in inflammatory and immune responses[5].
What are the key clinical trials for deucravacitinib?
The POETYK PSO clinical trial program includes multiple Phase 3 studies: POETYK PSO-1, POETYK PSO-2, POETYK PSO-3, POETYK PSO-4, and POETYK PSO-LTE, which evaluate the efficacy and safety of deucravacitinib in patients with moderate to severe plaque psoriasis[5].
What is the current regulatory status of deucravacitinib?
The FDA has accepted the NDA for deucravacitinib with a PDUFA goal date of September 10, 2022, and the EMA has validated the MAA. Japan's Ministry of Health, Labour and Welfare has also accepted the NDA for various forms of psoriasis[1].
How does deucravacitinib compare to other psoriasis treatments?
Deucravacitinib's unique mechanism of action and potential for a better safety profile, especially compared to JAK inhibitors, position it favorably in the competitive psoriasis market[2][5].
What is the projected market size for psoriasis treatments by 2034?
DelveInsight's analysts predict significant growth in the psoriasis market, with the US market size already at USD 17 billion in 2022 and expected to rise further due to increasing prevalence and new drug approvals[2].
Sources
- Bristol Myers Squibb. "Bristol Myers Squibb's Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency." November 29, 2021.
- PR Newswire. "Psoriasis Market to Register Incremental Growth by 2034, Predicts DelveInsight -- Key Companies -- AnaptysBio, Nimbus, Lakshmi, Takeda, Moonlake Immunotherapeutics, Bristol Myers Squibb, Amgen, Dermavant Sciences." June 24, 2024.
- UCSD Clinical Trials. "Long-Term Study That Measures the Safety and Efficacy of the Drug Deucravacitinib (BMS-986165) in Participants With Psoriasis." September 26, 2023.
- ACS Publications. "Highly Selective Inhibition of Tyrosine Kinase 2 (TYK2) for the Treatment of Autoimmune Diseases." July 18, 2019.
- Bristol Myers Squibb. "Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla (apremilast) in Pivotal Phase 3 Psoriasis Study." November 3, 2020.
