Ventyx Biosciences' Inflammatory Bowel Disease Candidate Flunks In Mid-Stage Study, Company Looks For Partner To Pursue It Further

Ventyx Biosciences Inc VTYX stock is trading lower on Monday.

The company released results from the Phase 2 trial of allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn’s disease, a type of inflammatory bowel disease that irritates and causes swelling in digestive tract.

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 that determines the current severity of Crohn’s disease) from baseline to Week 12.

A key secondary endpoint in this trial was the 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 due to a higher-than-anticipated placebo response.

A dose-dependent treatment effect was observed on the key secondary endpoint of endoscopic response at 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 the 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 data analyses. Currently, Ventyx does not anticipate conducting additional clinical trials of VTX958 with internal resources.

The company held cash, cash equivalents, and marketable securities of $279.7 million as of June-end, which is expected to fund planned operations into at least the second half of 2026.

Price Action: VTYX stock is down 24.6% at $2.225 at last check Monday.

Photo via Shutterstock

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