Ventyx scraps TYK2 inhibitorTYK2 inhibitor programme after second mid-stage setback
30 Jul 2024
Ventyx Biosciences’ shares plunged nearly 25% on Monday after a Phase II study of VTX958 to treat moderately-to-severely active Crohn’s disease failed to meet its primary endpoint. This marks the allosteric TYK2 inhibitorTYK2 inhibitor’s second mid-stage failure after it tanked in a plaque psoriasis study last November. The company noted it has no plans to pursue further clinical development of the oral therapy with its current internal resources.
The latest study randomised 109 participants to receive one of two doses of VTX958 or placebo for an induction period of 12 weeks, with a subsequent long-term extension phase. Results showed that the drug fell short on the primary endpoint of change in mean Crohn’s disease activity index (CDAI) score from baseline to week 12, which was attributed to a higher-than-expected placebo response.
Meanwhile, both dose groups reached nominal statistical significance on the key secondary endpoint of endoscopic response as measured by simple endoscopic score for Crohn’s disease (SES-CD), and showed greater reductions on C-reactive protein and faecal calprotectin, compared with placebo. Despite ending the TYK2 inhibitorTYK2 inhibitor’s clinical programme, the company will continue to analyse the data to understand the discrepancy between symptomatic and endoscopic response data.
Ventyx has been sailing in troubled waters on the development front since last year. A month before VTX958’s failure in the psoriasis trial, its oral S1P1 receptor modulator VTX002 for ulcerative colitis failed to live up to expectations in a Phase II study, despite hitting the primary endpoint. The company’s other pipeline assets include the peripheral NLRP3 inhibitor VTX2735NLRP3 inhibitor VTX2735 for familial cold autoinflammatory syndrome and the CNS-penetrant NLRP3 inhibitor VTX3232NLRP3 inhibitor VTX3232.
As of the end of June, the drugmaker held approximately $280 million in cash, equivalents and marketable securities, adequate to run operations until at least the second half of 2026.
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