Ventyx Provides Clinical and Corporate Updates
- Strengthening our Advisory Board with addition of Mark McKenna as Strategic Advisor and Peter Libby, MD as a Clinical Advisor
- Expanding the Phase 2 recurrent pericarditis study into Canada, EU and the UK to evaluate QD dose ranging in preparation for the global Phase 3 development plan
- Interim analysis for the ongoing Phase 2 recurrent pericarditis study to now be presented as part of Ventyx's R&D Day planned for Q1 2026
SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- 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.
About Ventyx Biosciences
Ventyx Biosciences is a clinical-stage biopharmaceutical company developing innovative oral therapies for patients with inflammation-meditated cardiovascular and neurodegenerative diseases. Our expertise in medicinal chemistry, structural biology, and immunology enables the discovery of differentiated oral small molecule therapeutics for conditions with high unmet medical need, and our extensive experience in clinical development allows the rapid progression of these drug candidates through clinical trials.
Our portfolio of NLRP3 inhibitors includes VTX2735, a peripherally restricted NLRP3 inhibitor in Phase 2 development for recurrent pericarditis, and VTX3232, a CNS-penetrant NLRP3 inhibitor that recently completed a Phase 2 study in participants with obesity and cardiovascular risk factors and a Phase 2a study in Parkinson's disease. Our inflammatory bowel disease portfolio includes two Phase 2 compounds: tamuzimod (VTX002), a S1P1R modulator and VTX958, a TYK2 inhibitor.
For more information on Ventyx, please visit our website at https://ventyxbio.com.
Forward Looking Statements
Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the timeline or scope of study expansion into any of Canada, the EU or the UK, the timing of reporting data from the Phase 2 trial in recurrent pericarditis in Q1 2026; the scope or nature of advice to be provided by Mr. McKenna and Dr. Libby; the scope, type or timing for introducing dose-ranging studies of VTX2735; the change in strategy of international expansion and conducting other studies will expedite the Phase 3 process; and the timing of, or content to be presented at, an R&D Day hosted by the Company.
The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; interim results not necessarily being predictive of final results; the potential of one or more outcomes to materially change as a trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; economic uncertainty in global markets caused by, among other things, geopolitical conditions, tariffs, military conflicts, and inflation volatility; unexpected adverse side effects or inadequate efficacy of Ventyx's product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx's ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx's prior press releases and Ventyx's filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed on November 6, 2025, and Ventyx's subsequent filings with the SEC.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact:
Alex Schwartz
Vice President, Investor Relations and FP&A
Ventyx Biosciences, Inc.
[email protected]
