NEW YORK CITY (dpa-AFX) - Drug maker Bristol-Myers Squibb Co. (BMY) Monday announced positive topline results from two pivotal Phase 3 trials evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis or PsA.
The Phase 3 Sotyktu PsA program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA.
Both POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) trials met their primary endpoint, which was the proportion of participants achieving an ACR20 response at Week 16.
In the trials, a significantly greater proportion of Sotyktu -treated patients achieved ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.
In addition, both trials met important secondary endpoints across PsA disease activity at Week 16.
The company noted that the overall safety profile of Sotyktu through 16 weeks of treatment in the two trials was consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
Bristol Myers will work with key investigators to present detailed results at upcoming medical congresses. The company added that patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study.
Roland Chen, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb, said, 'Psoriatic arthritis is a heterogenous disease that causes a range of different symptoms, including joint pain and swelling, as well as psoriatic skin lesions. 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...'
The company noted that these topline results represent the first Phase 3 clinical trials for Sotyktu in a rheumatic condition.
Sotyktu is approved in numerous countries worldwide for treating adults with moderate-to-severe plaque psoriasis.
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