BMS’ deucravacitinib psoriasis pill outperforms Amgen’s Otezla in phase 3

Bristol-Myers Squibb could be on the verge of a major coup in psoriasis after its deucravacitinib pill outperformed Amgen’s rival Otezla.

BMS had to sell off Otezla (apremilast) as a condition of its merger with Celgene and made Amgen pay $13.4 billion in cash for the popular pill treatment, which is not quite as effective as injections such as J&J’s Stelara (ustekinumab) but more convenient.

The reason why competition regulators were concerned about Otezla was BMS’ deucravacitinib, which was in Bristol’s pipeline when the $74 billion merger was being finalised last year.

Also known as BMS-986165, BMS was developing the drug as a potential best-in-class oral therapy with a different mechanism of action and cleaner safety profile.

Latest phase 3 results show that BMS may have played a blinder by getting a eye-watering price for Otezla while retaining the better asset: deucravacitinib has outperformed placebo in the POETYK PSO-1 phase 3 trial and met several secondary goals showing it outperformed Otezla while showing a safety profile similar to that seen in phase 2.

Results from the trial testing deucravacitinib in patients with moderate to severe disease showed more patients achieving 75% skin clearance compared with placebo at week 16.

Using a global scale, doctors scored more patients on deucravacitinib as clear or almost clear compared with placebo, meaning the trial’s other main endpoint was met.

BMS said deucravacitinib also beat Otezla on the 75% skin clearance score and the global doctors’ assessment.

BMS added that the overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported phase 2 results, where there was little to differentiate placebo and treatment groups.

Results of an almost identical phase 3 study, POETYK PSO-2 are due in the first quarter of next year and phase 2 findings will be presented at the American College of Rheumatology conference later this week.

Deucravacitinib has a different mechanism of action than other psoriasis drugs on the market – it is a tyrosine kinase 2 inhibitor that changes intracellular signalling and is also in development for several other inflammatory and immune diseases.

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