Bristol-Myers Squibb said it would begin global phase-3 trials on BMS-986165, an investigational drug for psoriasis, in Korea.
Unlike conventional psoriasis, BMS’ new treatment comes in an oral form. BMS-986165 has been drawing particular attention after it showed positive results in a phase-2 study in September.
The Ministry of Food and Drug Safety on Friday gave the nod to BMS to go ahead with the phase-3 test on the experimental medicine. The study will evaluate the efficacy and safety of BMS-986165 in 29 patients with moderate to severe psoriasis.
The phase-3 trials will be multi-center, randomized, double-blind, placebo-controlled, and active-drug controlled. They will take place at Seoul St. Mary's Hospital, Pusan National University Hospital, Severance Hospital, Chung-Ang University Hospital, Inha University Hospital, Bundang Seoul National University Hospital, Gachon University Medical Center’s Gil Oriental Medicine Hospital, and Hallym University Dongtan Sacred Heart Hospital.
BMS-986165 is selective tyrosine kinase2 (TYK2) inhibitor. The drugmaker is also carrying out trials of the drug in patients with systemic lupus erythematosus or Crohn’s disease.
The New England Journal of Medicine published the results of the phase-2 study of BMS-986165 in September. In the study, patients treated with the drug showed high PASI (Psoriasis Area and Severity Index) score.
The researchers administered the experimental treatment to 267 patients with moderate to severe psoriasis in six groups -- 44 patients with a daily dosage of 3mg, 45 patients with two-time dosages of 3mg a day, 44 patients with a 3mg dosage in every other day, 45 patients with two-time dosages of 6mg per day, 44 patients with a daily dosage of 12mg, and 45 patients with a placebo.
The results showed that patients with a dosage of 3mg or more achieved PASI score at between 75 and 90 after 12 weeks of treatment. The PASI score assesses the severity of psoriasis based on the extent of erythema, thickness of scalps and the extent of lesions.
PASI 90 means 90 percent of the symptoms improved and the patient almost recovered to clear skin. Common side effects of BMS-986165 include nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infections.