Ventyx Biosciences announced results from the Phase 2 trial of VTX958 in patients with moderate to severe plaque psoriasis and provided a corporate update.
The Phase 2 SERENITY trial of VTX958 was a 16-week, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating the efficacy and safety of four oral doses of VTX958 (50 mg BID, 300 mg QD, 225 mg BID, and 300 mg BID) in patients with moderate to severe plaque psoriasis. The primary endpoint was the proportion of participants achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) at Week 16. Both high doses of VTX958 (225 mg BID and 300 mg BID) achieved statistical significance on the primary endpoint and all key secondary endpoints at Week 16. No drug-related serious adverse events were observed.
Although the trial achieved its primary endpoint, the magnitude of efficacy observed did not meet our internal target to support advancement of VTX958 in plaque psoriasis. Accordingly, we will terminate ongoing activities in the Phase 2 plaque psoriasis trial effective immediately. Based on these results, we have also elected to terminate the ongoing Phase 2 trial of VTX958 in psoriatic arthritis. The ongoing Phase 2 trial of VTX958 in Crohn’s disease will continue to enroll and we intend to conduct an interim efficacy analysis in the first quarter of 2024.
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