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news.Bristol Myers Squibb (BMS) announced that its deucravacitinib (BMS-986165) has achieved both co-primary endpoints in the phase 3 psoriasis study.
Bristol Myers Squibb’s deucravacitinib has achieved co-primary endpoints in psoriasis study. (Credit: Rept0n1x)
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Deucravacitinib, a novel, oral and selective tyrosine kinase 2 (TYK2) inhibitor, is being assessed in clinical studies across multiple immune-mediated diseases such as psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease.
The phase 3 POETYK PSO-1 trial assessed 6mg of deucravacitinib once daily. It met both co-primary endpoints versus placebo in the trial.
The study also achieved multiple major secondary endpoints, including demonstrating deucravacitinib was superior to Otezla (apremilast).
POETYK PSO-1 is said to be the first of two global phase 3 studies designed to assess the safety and efficacy of deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis.
POETYK PSO-1 is a multi-centre, randomised, double-blind, placebo and active comparator-controlled phase 3 study, which recruited 666 participants diagnosed with moderate to severe plaque psoriasis.
The trial’s co-primary outcome measures include the percentage of participants who achieved psoriasis area and severity index (PASI) 75 and the percentage of participants who achieved static physician’s global assessment (sPGA) score of 0 to 1 at week 16 versus placebo.
Its major secondary outcome measures comprise percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at week 16.
The company plans to reveal the results from the second study called POETYK PSO-2 in the first quarter of 2021.
BMS global drug development chief medical officer and executive vice president Dr 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.”
In October this year, BMS signed an agreement to acquire clinical-stage biopharmaceutical company MyoKardia for $13.1bn.
MyoKardia is engaged in the discovery and development of targeted therapies to treat serious cardiovascular diseases.
