Ventyx Biosciences Reports Phase 2 Trial Results of VTX958 in Active Crohn’s Disease

Ventyx Biosciences, Inc., a clinical-stage biopharmaceutical company based in San Diego, California, recently reported the results of its Phase 2 trial for VTX958, an allosteric TYK2 inhibitor, in patients with moderate to severe Crohn’s disease. Despite some promising outcomes, the trial did not meet its primary endpoint.

The Phase 2 trial involved 109 participants who were randomized into three groups receiving either 225 mg or 300 mg doses of VTX958 twice daily or a placebo over a 12-week induction treatment period. This was followed by a long-term extension phase. The primary goal was to observe changes in the mean Crohn’s Disease Activity Index (CDAI) score from baseline to Week 12. A crucial secondary endpoint was measuring endoscopic response, defined as a 50% reduction in the simple endoscopic score for Crohn’s disease (SES-CD).

Unfortunately, the trial did not achieve its primary endpoint due to an unexpectedly high placebo response. However, a dose-dependent improvement was observed in the secondary endpoint of endoscopic response at both dose levels. The 225 mg and 300 mg doses showed nominal statistical significance with p-values of less than 0.05 and less than 0.01, respectively. This endoscopic response, assessed through centrally read endoscopy, is considered a critical and objective measure of treatment efficacy.

Additionally, both doses of VTX958 demonstrated a greater reduction in two key inflammatory biomarkers, C-reactive protein, and fecal calprotectin, compared to placebo. The drug was well tolerated by participants, and the safety profile aligned with previous studies conducted for VTX958.

Given these mixed results, Ventyx plans to conduct further analyses to understand better the discrepancy between symptomatic improvements, as measured by CDAI, and endoscopic outcomes. However, the company has no current plans to pursue additional clinical trials for VTX958 using internal resources.

As of June 30, 2024, Ventyx held $279.7 million in cash, cash equivalents, and marketable securities. The company believes this amount is sufficient to fund its planned operations until at least the second half of 2026.

Ventyx Biosciences focuses on developing innovative oral medications for autoimmune and inflammatory conditions. The company aims to revolutionize the inflammation and immunology markets, traditionally dominated by injectable treatments, by introducing effective oral therapies. Their current pipeline includes clinical programs targeting NLRP3, S1P1R, and TYK2, positioning Ventyx as a leader in developing oral immunology treatments for both peripheral and neuroinflammatory diseases.

Through its dedication to discovering and developing novel drug candidates, Ventyx hopes to address significant unmet medical needs and improve the quality of life for patients with autoimmune and inflammatory disorders.