Bristol Myers Squibb (BMS) has announced that a Phase III trial showed superiority of deucravacitinib (BMS-986165) to placebo or Otezla (apremilast) in treating patients with moderate to severe plaque psoriasis.
Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor currently being studied in clinical trials across multiple immune-mediated diseases.
The Phase III PrOgram to Evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor PSO-1 (POETYK PSO-1) trial analysed safety and efficacy of deucravacitinib compared to placebo and Otezla (apremilast) in patients with moderate to severe plaque psoriasis.
The multi-centre, randomised, double-blind, placebo and active comparator-controlled trial enrolled 666 participants with moderate to severe plaque psoriasis who were given 6mg of deucravacitinib once daily or placebo.
Results showed that the trial met both co-primary endpoints.
More patients on deucravacitinib achieved Psoriasis Area and Severity Index (PASI) 75, defined as at least a 75% improvement in PASI.
They also achieved a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment.
The trial also met multiple key secondary endpoints showing deucravacitinib was superior to Otezla in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at week 16.
Deucravacitinib’s safety profile in the trial was consistent with previously found ones.
Bristol Myers Squibb global drug development executive vice-president, chief medical officer Samit Hirawat said: “We are encouraged by the efficacy and safety profile observed in the POETYK PSO-1 study, which supports the strong potential we see for deucravacitinib, our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis.”
Detailed data from the POETYK PSO-1 trial will be shared soon, while results from the second study, POETYK PSO-2, are anticipated in the first quarter of next year.
Last month, BMS reported positive additional results from the Phase III True North trial of oral Zeposia in adults with moderate to severe ulcerative colitis.