Bristol-Myers Squibb announced that its Phase II clinical trial of BMS-986165 for moderate to severe plaque psoriasis hit its efficacy endpoints.
Bristol-Myers Squibb announced that its Phase II clinical trial of BMS-986165 for moderate to severe plaque psoriasis hit its efficacy endpoints.
BMS-986165 is an oral, selective tyrosine kinase 2 (TYK2) inhibitor. In the trial, it showed a greater than or equal to 75 percent and 90 percent decrease in the Psoriasis Area and Severity Index (PASI) after 12 weeks of treatment with a 3 milligram or greater daily dose of the drug. It has a favorable risk-benefit profile, with nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection cited as the most common side effects.
The results were published in the New England Journal of Medicine and will be presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress held in Paris. The company also plans to present data from the trial describing changes in biomarkers and the selectivity of the therapy for TYK2 as it relates to clinical responses at EADV on September 15.
“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, head of Bristol-Myers Squibb’s Innovative Medicines Development, in a statement. “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.”
Bristol-Myers is currently enrolling patients for a Phase III trial of the drug and is also testing it in patients with lupus or Crohn’s disease.
Reuters writes, “An approval by the U.S. Food and Drug Administration (FDA) for the plaque psoriasis treatment will offer Bristol-Myers, which relies heavily on its blockbuster cancer drug Opdivo, a chance to diversify its portfolio. The FDA earlier this year declined to approve Bausch Health Cos Inc’s plaque psoriasis lotion Duobrii and analysts now expect that drug to hit market only after 2019.”
The Phase II trial randomized 267 patients to receive BMS-986165 in doses of 3 mg every other day, 3 mg every day, 3 mg twice daily, 6 mg BID, 12 QD, or placebo. The primary endpoint was PASI 75 at Week 12. Key secondary endpoints were the same metrics at 90 percent and 100 percent (PASI 90 and PASI 100) in addition to Dermatology Life Quality Index (DLQI).
The drug achieved PASI 75 in 67 to 75 percent of patients in those receiving 3 mg twice a day and higher dose groups, compared to 7 percent for placebo at Week 12. The PASI 75 response rates were 7 percent for placebo, 9 percent for 3 mg QOD, 39 percent for 3 mg QD, 69 percent for 3 mg BID, 67 percent for 6 mg BID, and 75 percent for 12 mg QD.
Three serious adverse effects were reported in the active groups and two in the placebo group. No serious side effects were observed in the highest dose groups.
“Currently, patients with moderate to severe psoriasis have a limited number of oral therapies,” stated Kim Papp of Probity Medical Research in Waterloo, Ontario and lead author of the New England Journal of Medicine article. “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.”
