Bristol-Myers Squibb begins phase 3 enrollment after psoriasis drug shows high skin clearance

An oral tyrosine kinase 2 inhibitor from Bristol-Myers Squibb has checked off a phase 2 trial in plaque psoriasis, achieving high levels of skin clearance after three months of daily treatment.

In response, the big biotech has begun enrolling patients with moderate-to-severe psoriasis in a registrational phase 3 study of the drug, known as BMS-986165. Additional phase 2 trials in lupus and Crohn’s disease are ongoing, and the company is planning to study the drug in a wide array of immune-mediated diseases.

The study randomized 267 patients to five increasing doses and placebo. For the study’s primary endpoint, two-thirds to three-quarters of patients receiving 3 mg twice daily or more showed at least 75% skin clearance after 12 weeks, compared to 7% of patients taking placebo.

About 44% of patients taking the same amounts showed 90% skin clearance—while 25% of patients receiving the highest dose, 12 mg daily, demonstrated complete clearance of lesions.

“Currently, patients with moderate-to-severe psoriasis have a limited number of oral therapies,” said Kim Papp, M.D., Ph.D., of Probity Medical Research in Waterloo, Ontario, and lead author of the study’s publication in the New England Journal of Medicine.

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“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,” Papp added. The study results were also presented at the European Academy of Dermatology and Venerology Congress in Paris.

BMS described the drug as having a favorable risk-benefit profile, with nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infections being the most commonly reported adverse events in the study.

There were three serious AEs reported in the trial’s active groups and two in the placebo group, with none occurring in the highest-dose groups of 6 mg twice daily and 12 mg once daily, the company said.