Ventyx Biosciences, Inc. (NASDAQ: VTYX) ("Ventyx", "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with inflammation-mediated cardiovascular and neurodegenerative diseases, today announced that the Company added two leading experts to their advisory board and provided an update to its ongoing Phase 2 study of VTX2735 in patients with recurrent pericarditis ("RP").
"We are fortunate to attract such an outstanding group of scientists, clinicians and strategic advisors to work with us. Mr. McKenna and Dr. Libby's expertise will be invaluable as we continue to evaluate clinical and strategic options for our oral NLRP3 portfolio," said Raju Mohan, PhD, Chief Executive Officer. "They will advise us on key decisions with respect to VTX3232, our CNS-penetrant NLRP3 inhibitor, that generated two positive Phase 2 data sets earlier this year, and VTX2735, our peripherally restricted NLRP3 inhibitor, that is in an ongoing Phase 2 study in patients with recurrent pericarditis."
"We are also revising our guidance for topline data release from the interim analysis of the Phase 2 RP trial to Q1 2026. While the timing represents a modest shift from our prior guidance it also provides us with an opportunity to introduce dose-ranging studies with our new once-daily or QD formulation in the current Phase 2 study while also expanding into Canada, EU and the UK, a strategy we feel will accelerate Phase 3 timelines," added Dr. Mohan. "We plan to host a R&D Day in Q1 2026 where, in addition to the interim Phase 2 RP data, we will also highlight the pharmacokinetic and pharmacodynamic characteristics of the QD formulation as well as provide an update on our discovery portfolio."
Ventyx adds Strategic Advisor and Expands Clinical Advisory Board
Mark McKenna, MBA, Strategic Advisor. Mr. McKenna is the founder, Chairman and Chief Executive Officer of Mirador Therapeutics, a precision medicine company focused on immunology and inflammation. Mark previously served as Chairman, President and Chief Executive Officer of Prometheus Biosciences from 2019-2023. Prometheus created the first precision therapeutics for immune-mediated diseases. It was acquired by Merck for $10.8B in June 2023.
Peter Libby, MD, Clinical Advisor. Dr. Libby is a cardiovascular specialist at Mass General Brigham Heart & Vascular Institute and immediate past president of the International Atherosclerosis Society. His area of clinical expertise includes general and preventive cardiology. His research is focused on the role of inflammation in vascular diseases, such as atherosclerosis. Dr. Libby instigated and helped lead the Canakinumab Anti-Inflammatory Thrombosis Outcomes Trial (CANTOS) that provided clinical validation of the role of inflammation in atherosclerosis.
Ongoing Phase 2 Study of VTX2735 in Patients with Recurrent Pericarditis
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 ( NCT06836232). 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 (NRS) pain score, and change in high sensitivity C-reactive protein (hsCRP).
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. We 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. We plan to present the topline data at our R&D Day planned for Q1 2026.