Ventyx Biosciences Announces Completion of Enrollment of the Phase 2 Trial of VTX002 in Ulcerative Colitis and the Phase 2 Trial of VTX958 in Plaque Psoriasis

Topline results from the Phase 2 trial of VTX002 (S1P1R modulator) in ulcerative colitis and the Phase 2 trial of VTX958 (TYK2 inhibitor) in plaque psoriasis are expected in Q4 2023

ENCINITAS, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that the Company has completed patient enrollment in the Phase 2 trial of VTX002 in ulcerative colitis and the Phase 2 SERENITY trial of VTX958 in plaque psoriasis.

“I am very proud of our team’s execution as we mark another important milestone for Ventyx and for ulcerative colitis and plaque psoriasis patients,” said Dr. William Sandborn, President and Chief Medical Officer. “We believe the robust enrollment activity in these trials demonstrates tremendous interest from patients and investigators in novel oral therapies for autoimmune diseases. We look forward to reporting topline data from the Phase 2 trial of VTX002 in ulcerative colitis early in the fourth quarter of 2023, followed by topline results from the Phase 2 SERENITY trial of VTX958 in plaque psoriasis, which are also expected in the fourth quarter of 2023.”

The Phase 2 trial of VTX002, an oral, selective, peripherally restricted S1P1R modulator, is a randomized, double-blind, placebo-controlled clinical trial in patients with moderately to severely active ulcerative colitis. The trial design includes a target enrollment of approximately 180 patients randomized to one of two VTX002 doses or placebo for a 13-week induction treatment period, followed by a 39-week blinded long-term extension period. The primary efficacy endpoint is the proportion of subjects achieving clinical remission at Week 13 as defined by the modified Mayo Score.

The Phase 2 SERENITY trial of VTX958, an oral, selective, allosteric TYK2 inhibitor, is a randomized, double-blind, placebo-controlled, dose-ranging trial in patients with moderate to severe plaque psoriasis. The trial design includes a target enrollment of approximately 200 patients randomized to one of four VTX958 doses or placebo for a 16-week treatment period, followed by a 16-week blinded long-term extension period. The primary efficacy endpoint is the proportion of subjects achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) at week 16.