Bristol-Myers Squibb has reported that its oral, selective tyrosine kinase 2 (TYK2) inhibitor BMS-986165, yielded positive results in a phase 2 trial in patients with moderate to severe plaque psoriasis, by reducing the severity of their skin disorder.
The trial, dubbed IM011-011, enrolled 267 patients to assess the efficacy and safety of BMS-986165 in comparison to placebo. It delivered significant skin clearance, said the US pharma company.
Bristol-Myers Squibb said that after 12 weeks of daily treatment with a dosage of 3mg or more of BMS-986165, the efficacy endpoints of the trial including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved.
Further, the company said that there was a favorable risk-benefit profile for the dosage of the TYK2 inhibitor.
PASI 75 was defined to be the primary endpoint of the trial at week 12, which was achieved in 67-75% of patients, who were subjected to BMS-986165. In contrast, PASI 75 response rates in the placebo arm were achieved by 7% of the patients.
Bristol-Myers Squibb innovative medicines development head Mary Beth Harler said: “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.
“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 Squibb said that it is currently enrolling patients with moderate to severe plaque psoriasis for the POETYK PSO phase 3 program to evaluate the efficacy and safety of BMS-986165 in patients with moderate to severe plaque psoriasis.
In addition to that, the company is engaged in phase 2 trials of BMS-986165 in patients with systemic lupus erythematosus or Crohn’s disease.
One of the phase 2 trials is the result of Bristol-Myers Squibb’s collaboration with Lupus Therapeutics, an affiliate of Lupus Research Alliance, to evaluate BMS-986165 as a potential new treatment for lupus.