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

Ventyx Biosciences, Inc. recently announced it 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.

In addition to the Phase 2 SERENITY trial, Phase 2 trials of VTX958 continue to enroll patients in moderately to severely active Crohn’s disease (HARMONY) and in active psoriatic arthritis (TRANQUILITY), with topline results from both trials expected in 2024.

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 internally discovered clinical 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.