Ventyx Biosciences Announces Dosing of the First Patient in Phase 2 SERENITY Trial for the Treatment of Moderate-to-Severe Plaque Psoriasis
Ventyx Biosciences, Inc. recently announced the first patient has been dosed in a Phase 2 trial of its selective, allosteric TYK2 inhibitor VTX958 for the treatment of moderate to severe plaque psoriasis.
“Dosing of the first patient in the Phase 2 SERENITY trial of VTX958 is a major accomplishment for Ventyx and an important step towards providing a new treatment option for patients suffering from moderate to severe plaque psoriasis who are in need of more effective oral therapies,” said Dr. William Sandborn, President and Chief Medical Officer. “Our Phase 1 single-ascending dose and multiple-ascending dose data established an excellent safety profile with dose-dependent pharmacokinetic and pharmacodynamic data supporting class-leading target coverage of TYK2-mediated pathways. The wide therapeutic window of VTX958 observed in our Phase 1 trial will allow us to explore a broad range of doses in Phase 2 trials, including doses designed to achieve biologic-like IC90 coverage of TYK2-mediated cytokines, such as IL-23. Topline data from the Phase 2 SERENITY trial are expected in the fourth quarter of 2023. We plan to provide further updates across our wholly-owned development pipeline, including our three Phase 2 trials of VTX958, at our R&D day on January 26, 2023.”
The Phase 2 SERENITY trial is a randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate the safety and efficacy of VTX958 in patients with moderate to severe plaque psoriasis. The trial will enroll approximately 200 patients randomized to one of four VTX958 doses or placebo for a 16-week double-blind treatment period. The primary efficacy endpoint will evaluate the proportion of subjects achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) at week 16.
In addition to the SERENITY Phase 2 trial, Ventyx is on track to initiate two additional Phase 2 trials of VTX958 in psoriatic arthritis and Crohn’s disease before the end of the year.
Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift immunology markets from injectable to oral drugs. Our current pipeline includes three clinical-stage internally discovered programs targeting TYK2, S1P1R and NLRP3, positioning us to become a leader in the development of oral immunology therapies. Ventyx is headquartered in Encinitas, California. For more information, visit www.ventyxbio.com.
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