Bristol Myers Squibb (BMS) has announced positive results from the second pivotal Phase III trial of deucravacitinib 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 deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-2 study analysed the safety and efficacy of deucravacitinib versus placebo and Otezla (apremilast) in moderate to severe plaque psoriasis patients.
The multi-centre, randomised, double-blind trial enrolled 1,020 patients who were given 6mg of deucravacitinib once daily or placebo and Otezla (apremilast) 30mg twice daily.
In addition, the trial had a randomised withdrawal and retreatment period after 24 weeks.
Data showed that it met both co-primary endpoints versus placebo.
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.
Furthermore, the trial 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.
The safety profile of deucravacitinib in the trial was consistent with previously reported ones and with its mechanism of action.
Bristol Myers Squibb global drug development executive vice-president, chief medical officer Samit Hirawat said: “The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule.
“The encouraging data we have seen to date suggest deucravacitinib may become an important oral treatment option for people living with psoriasis.”
The company noted that POETYK PSO-2 is the second of two global Phase III studies showing the superiority of once-daily dose of deucravacitinib.
Last November, BMS reported positive topline results from the first Phase III trial, POETYK PSO-1.