Safety and Efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the Phase 2 STRIDE study

Envudeucitinib (ESK-001), a highly selective, oral TYK2 inhibitor, was well-tolerated and effective in patients with plaque psoriasis in the STRIDE study. To assess long-term safety and efficacy of envudeucitinib throughout 52 weeks in the ongoing Phase 2 open-label extension (OLE) in patients who completed STRIDE. Patients completing STRIDE were eligible to enroll in the long-term OLE study (NCT05739435) and received envudeucitinib 40 mg once (QD) or twice daily (BID). In the OLE which enrolled 165 patients, envudeucitinib was generally well-tolerated, with an overall 3.7% study drug discontinuation rate due to adverse events, as well as no clinically concerning laboratory or electrocardiogram findings. After 52 weeks of treatment with envudeucitinib 40 mg BID, 78% of patients achieved PASI-75, 61% achieved PASI-90, 39% achieved PASI-100, and 39% achieved sPGA-0. Moreover, 62% showed continued improvement in PASI response over time versus STRIDE Week 12. In addition, approximately 80% reported pruritus NRS <4 and 61% achieved DLQI 0/1. This was an open-label study with limited sample size and no control. Envudeucitinib 40 mg BID in adults with moderate-to-severe plaque psoriasis demonstrated increasing and durable improvements in skin clearance and pruritus and was well-tolerated throughout 52 weeks of treatment.