Unsuccessful results were reported from a phase 2 trial of the drug, VTX958, aimed at treating moderately to severely active Crohn’s disease. The trial did not meet its primary endpoint of improving the mean Crohn’s Disease Activity Index score at week 12, largely due to an unexpectedly high placebo response. Although the drug showed promise in phase 1 trials, with VTX958’s mechanism targeting TYK2—a regulator of immune response—the latest findings have led Ventyx Biosciences to reconsider further trials without external support. The company will instead focus on analyzing the current data to resolve the differences observed between symptomatic and endoscopic outcomes.
Despite a strategic plan to expand VTX958 testing into multiple phase 2 trials, the drug’s performance has not met the company’s internal criteria for advancement in these areas. The ongoing trial in Crohn’s disease, which involved 109 participants over a 12-week period, showed a dose-dependent improvement in endoscopic responses and decreases in inflammation markers, yet, it failed to significantly impact the primary symptomatic measure.
Reference: Brooks A. VTX958 Misses Primary Endpoint for CDAI Change in Phase 2 Crohn’s Disease Trial. HCP Live. Published July 29, 2024. Accessed September 4, 2024. https://www.hcplive.com/view/vtx958-misses-primary-endpoint-cdai-change-phase-2-crohn-disease-trial
Link: https://www.hcplive.com/view/vtx958-misses-primary-endpoint-cdai-change-phase-2-crohn-disease-trial
