Ventyx Ends TYK2 Inhibitor Program After Second Mid-Stage Failure

Ventyx Biosciences experienced a significant drop in its stock price, plummeting nearly 25% on Monday, following the disappointing results of a Phase II study involving VTX958 for treating moderately-to-severely active Crohn’s disease. The study's failure to meet its primary endpoint marked the second setback for the allosteric TYK2 inhibitor, which had previously failed in a mid-stage plaque psoriasis study in November of the prior year. Consequently, Ventyx announced that it has no intention of continuing the clinical development of this oral therapy using its current internal resources.

The recent study involved 109 participants who were randomly assigned to receive one of two dosages of VTX958 or a placebo over a 12-week induction period, followed by a long-term extension phase. Unfortunately, the drug did not achieve the primary endpoint, which was the change in mean Crohn’s disease activity index (CDAI) score from the baseline to week 12. This shortfall was attributed to an unexpectedly high placebo response. However, the treatment did show promise in other areas. Both dosage groups achieved nominal statistical significance on a key secondary endpoint, which was the endoscopic response measured by the simple endoscopic score for Crohn’s disease (SES-CD). Additionally, there were more significant reductions in C-reactive protein and fecal calprotectin levels in comparison to the placebo group. Despite these positive secondary outcomes, Ventyx has decided to discontinue the TYK2 inhibitor’s clinical program but will continue to analyze the data to understand the discrepancies between symptomatic and endoscopic response results.

The past year has been challenging for Ventyx Biosciences in terms of drug development. Just a month before the Crohn’s disease trial's disappointing results, the company experienced another setback. Its oral S1P1 receptor modulator VTX002, intended for the treatment of ulcerative colitis, also underperformed in a Phase II study despite meeting its primary endpoint. These repeated setbacks have put Ventyx in a difficult position regarding its development pipeline.

Besides VTX958 and VTX002, Ventyx’s other pipeline assets include VTX2735, a peripheral NLRP3 inhibitor aimed at treating familial cold autoinflammatory syndrome, and VTX3232, a CNS-penetrant NLRP3 inhibitor.

As of the end of June, Ventyx Biosciences had approximately $280 million in cash, equivalents, and marketable securities. This financial cushion is projected to be sufficient to sustain the company's operations until at least the latter half of 2026. This financial stability provides a timeframe for Ventyx to strategize its next steps and potentially focus on other promising areas within its drug pipeline.

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