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Ventyx Biosciences provides update on ongoing Phase 2 study of VTX2735

Recurrent pericarditis is condition in which the pericardium, a double-layered sac that surrounds and protects the heart, is inflamed and subsequent flaring leads to severe pain and heart complications. The NLRP3 inflammasome is believed to be a major instigator of the aberrant immune response in the pericardium of RP patients. By targeting NLRP3, VTX2735 has the potential to treat patients experiencing an active flare and prevent future recurrences, streamlining the treatment for patients with recurrent pericarditis. VTX2735 is being evaluated in an ongoing, multicenter, open-label Phase 2 study in patients with severe recurrent pericarditis. The study is currently evaluating a 150 mg BID dosing regimen with the primary endpoint of the study measured at week 6, with eligible patients who meet the criteria for continuation, evaluated up to 13 weeks during the extension period. Key endpoints include safety, change in the numerical rating scale pain score, and change in high sensitivity C-reactive protein. Additionally, the Company has received Health Canada regulatory approval to activate clinical sites by end of December and has initiated the CTA filing process in the EU and the UK. The company will switch to a QD dose starting in December with the primary endpoint for the QD cohorts still assessed at week 6 but the extension period will now extend through 24 weeks. The company plans to present the topline data at its R&D Day planned for Q1 2026.

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