Ventyx Biosciences Announces Results From Phase 2 Trial of VTX958 in Participants With Moderately to Severely Active Crohn’s Disease
Ventyx Biosciences, Inc. recently announced results from the Phase 2 trial of its allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn’s disease. The Phase 2 trial enrolled 109 participants randomized to one of two VTX958 doses (225 mg and 300 mg twice daily) or placebo for a 12-week induction treatment period, followed by a long-term extension period. The primary endpoint was the change in the mean Crohn’s disease activity index (CDAI) score (a patient reported outcome) from baseline to Week 12. A key secondary endpoint in this trial was endoscopic response, defined as a 50% reduction in the simple endoscopic score for Crohn’s disease (SES-CD). The trial did not meet its primary endpoint of change in mean CDAI score from baseline to Week 12 due to a higher than anticipated placebo response.
A dose-dependent treatment effect was observed on the key secondary endpoint of endoscopic response, at both the 225 mg and 300 mg doses (nominal p-value <0.05 and <0.01, respectively). Endoscopic response, evaluated by centrally read endoscopy, is considered an objective outcome and a high priority treatment goal. Both doses of VTX958 also showed a greater magnitude of decrease compared to placebo in two key biomarkers of inflammation, C-reactive protein and fecal calprotectin. VTX958 was well tolerated in the Phase 2 trial. The overall safety profile was consistent with previously conducted trials of VTX958.
Based on these results, the company intends to conduct further analyses of the data to better understand the discordance between symptomatic and endoscopic response data. At this time, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources.
The company held cash, cash equivalents and marketable securities of $279.7M as of June 30, 2024, which we continue to believe are sufficient to fund planned operations into at least the second half of 2026.
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 inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information, visit www.ventyxbio.com.
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