Bristol-Myers Squibb Company (BMY.US) TYK2 inhibitor achieves two key phase 3 clinical trial primary endpoints.

Bristol-Myers Squibb Company (Bristol Myers Squibb) (BMY.US) announced today positive results from the POETYK PsA-1 and POETYK PsA-2 trials. These two key phase 3 clinical trials evaluated the efficacy and safety of the tyrosine kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The trial results showed that both studies met their primary endpoints, with a significantly higher proportion of patients receiving Sotyktu reaching the ACR20 (at least 20% improvement in disease signs and symptoms) at 16 weeks compared to placebo. The press release noted that these top-line results mark the completion of phase 3 clinical trials for Sotyktu in a rheumatic disease for the first time. In addition, the POETYK PsA-1 and POETYK PsA-2 trials also met important secondary endpoints related to PsA disease activity at week 16. The overall safety of Sotyktu in these two trials was consistent with its known safety profile observed in 2-phase clinical trials for PsA and phase 3 clinical trials for moderate to severe plaque psoriasis. Bristol-Myers Squibb Company plans to collaborate with key investigators to present detailed study results at upcoming medical conferences. Sotyktu (deucravacitinib) is an oral selective bispecific TYK2 inhibitor with a unique mechanism of action. It achieves high selectivity by binding to the regulatory domain of TYK2, providing bispecific inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations and does not inhibit JAK1, JAK2, or JAK3 at therapeutic doses. Sotyktu is currently approved in multiple countries and regions for the treatment of adults with moderate to severe plaque psoriasis.