Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165
Data published in New England Journal of Medicine and presented at European Academy of Dermatology and Venerology Congress
Late-stage development program initiated in psoriasis and other immune-mediated diseases
Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165, with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported.
These data were published in the New England Journal of Medicine and presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. In addition, data from the Phase 2 study describing biomarker changes and the selectivity of BMS-986165 for TYK2 in relation to clinical responses will be presented at EADV on Sept. 15, during a late-breaker session.
“Moderate to severe psoriasis remains undertreated and many patients struggle with insufficient disease control, leaving a significant need for effective and convenient therapies that can provide a positive impact on patients’ lives,” said Mary Beth Harler, M.D., head of Innovative Medicines Development, Bristol-Myers Squibb. “BMS-986165 is a novel, oral, selective TYK2 inhibitor with a distinct mechanism of action that has the potential to help psoriasis patients control their disease, and is planned for study in a wide spectrum of immune-mediated diseases.”
“Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,” said Dr. Kim Papp, M.D., Ph.D., of Probity Medical Research in Waterloo, Ontario and lead author of the New England Journal of Medicine publication. “Having a favorable risk-benefit profile and delivering significant skin clearance and improvements in quality of life measures, these data suggest that BMS-986165 may be a promising oral option to help patients control their psoriasis in the future.”
The registrational POETYK (PrOgram to Evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor) PSO Phase 3 program for patients with moderate to severe plaque psoriasis is currently enrolling. Phase 2 trials for patients with systemic lupus erythematosus or Crohn’s disease are also ongoing.
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