Bristol Myers Squibb (BMS) has announced positive topline results from two Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA), with both trials hitting their endpoints.
In both trials, patients treated with Sotyktu, saw a greater treatment response, as measured by the American College of Rheumatology (ARC20) scale, in signs and symptoms of disease after 16 weeks, compared to those on placebo. The ACR20 scale indicates at least 20% improvement in signs and symptoms of the disease. While the company did not release detailed data, it plans to present the results at a future medical meeting.
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Sotyktu is approved to treat plaque psoriasis by the US Food and Drug Administration (FDA).
The first trial, POETYK PsA-1 (NCT04908202) enrolled approximately 670 patients with active PsA who had not been previously treated with a biologic disease-modifying antirheumatic drug (bDMARD-naïve). POETYK PsA-2 (NCT04908189) enrolled approximately 730 patients with active PsA who were bDMARD-naïve or had previously received TNFα inhibitor treatment. After completing 52 weeks of treatment, patients from both trials are potentially eligible to enrol in the upcoming open-label extension study.
Both trials also met important secondary endpoints evaluating PsA disease activity after 16 weeks.
Roland Chen, senior vice president and head of immunology, cardiovascular and neuroscience development at Bristol Myers Squibb, said: “Despite available therapies, rheumatologists continue to express a need for a safe and effective oral treatment. These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu.”
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By GlobalDataDescribed as an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, Sotyktu saw sales of $170m in 2023 according to GlobalData. That figure is then thought to have risen to $318m by the end of this year and is forecasted to continue rising to $2.2bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the arthritis therapies market, Aclaris Therapeutics stock took a hit after the company announced it will discontinue the development of zunsemetinib after a Phase IIb trial in rheumatoid arthritis failed to meet its primary and secondary endpoints. Last year, Takeda announced that a psoriatic arthritis Phase IIb trial with its own TYK2 inhibitor, TAK-279, met its primary endpoint, prompting further clinical development.
