Ventyx's Inflammatory Med Fails in Phase 2 Crohn's Trial

Ventyx Biosciences recently announced disappointing results from their phase 2 trial of VTX958, a medication aimed at treating Crohn’s disease. This trial involved 109 patients with moderately to severely active Crohn’s disease, who were administered one of two doses of VTX958 or a placebo over a 12-week period, followed by a long-term follow-up. The trial was designed to measure changes in the Crohn’s disease activity index, a standard scale for assessing the severity of the disease. Unfortunately, the trial did not meet its primary endpoint, which was to show a statistically significant improvement in patients taking VTX958 compared to those taking the placebo. Ventyx attributed this failure to an unexpectedly high placebo response.

Due to these results, Ventyx has decided not to allocate additional internal resources for further testing of VTX958 for Crohn’s disease. However, the company noted that VTX958 did show a dose-dependent effect on a key secondary endpoint related to endoscopic response, which is considered an important and objective measure of treatment efficacy. Both doses of the drug also resulted in a reduction of two significant inflammation markers. Given these mixed outcomes, Ventyx plans to conduct a thorough analysis to understand the discrepancy between endoscopic and symptomatic results.

The news had a significant impact on Ventyx’s stock, which dropped approximately 23% in early trading on Monday, falling from $2.95 to $2.48 per share. As of June 30, Ventyx reported having $279.7 million in cash, enough to fund operations into the second half of 2026.

This setback with VTX958 is not the first for Ventyx. In November 2023, the drug yielded mixed results in a mid-stage study for treating psoriasis, failing to meet the company's efficacy targets. This led to Ventyx discontinuing the development of VTX958 for psoriasis and psoriatic arthritis. Following the psoriasis trial failure, Ventyx's stock plummeted by 73% to $3.77, prompting the company to lay off 20% of its workforce.

Despite the challenges with VTX958, Ventyx continues to advance other drugs in its pipeline. Among them is VTX002, which is being developed to treat ulcerative colitis. The company has completed a phase 2 trial for VTX002 and announced in May that it is seeking partners for the late-stage development of this drug.

Ventyx’s CEO, Raju Mohan, Ph.D., had previously described the Crohn's disease trial as a "much bigger opportunity" following the psoriasis trial setbacks. With VTX958 now sidelined, the company’s focus will likely shift more towards its remaining drug candidates as it continues to navigate the challenges of drug development in the competitive biotech landscape.