NodThera Announces the Publication and Presentation of Cardiometabolic Clinical Data Supporting the Potential of Ruvonoflast to Treat Inflammation at the Source

Data published in the Journal of the American College of Cardiology Represents first peer-reviewed publication of clinical data demonstrating reductions in cardiometabolic risk markers with NLRP3 inhibitor 

Simultaneous late-breaking presentation of these data at the 94th European Atherosclerosis Society Congress

NodThera is preparing to advance ruvonoflast into Phase 3 cardiometabolic development following the RESOLVE-1 trial readout expected in Q3 2026

BOSTON, May 26, 2026 (GLOBE NEWSWIRE) -- NodThera, the leading clinical-stage NLRP3 company developing a portfolio of potentially best-in-class brain-penetrant oral NLRP3 inhibitors to address inflammatory drivers of cardiometabolic and neurologic diseases, today announced the publication of positive data from its clinical trial evaluating the effects of ruvonoflast, previously known as NT-0796, in patients with cardiometabolic disease, in the Journal of the American College of Cardiology (JACC)¹. Concurrently, these data are being presented in a late-breaking oral session being held today at the 94th European Atherosclerosis Society (EAS) Congress in Athens, Greece.

“Inflammation is a causal, modifiable risk factor for atherosclerotic disease,” said Prof. Paul Ridker of the Harvard Medical School. “Our field now stands at an important inflection point, with multiple anti-inflammatory therapies in late-stage development. If also proven successful at reducing cardiovascular events, oral anti-inflammatory options that are scalable would be a welcome addition to our growing cardiovascular armamentarium.”

Data published and presented include the results from a randomized, double-blind, placebo-controlled study to assess the effect of ruvonoflast on inflammation in participants at risk of cardiovascular disease (NCT06129409).

Highlights:

• Data provides evidence that upstream inhibition of the NLRP3/IL-1/IL-6/IL-18 inflammation pathway can achieve clinically significant reductions in validated biomarkers of cardiovascular risk.
  • Ruvonoflast lowered hsCRP, a well-validated, independent, modifiable marker of inflammation associated with ASCVD events, by 82% in patients at high risk of ASCVD.
  • 76% of ruvonoflast-treated patients achieved hsCRP <2 mg/L, the threshold shown to be associated with 25% MACE reduction in the landmark CANTOS cardiovascular outcome trial².
  • Ruvonoflast effects on hsCRP were rapid, sustained and readily reversible, a potentially key differentiator versus injectable biologics.
• Ruvonoflast significantly reduced key thrombo-inflammatory biomarkers beyond hsCRP, including IL-6, fibrinogen, and Lp(a). Taken together, these data underpin the anti-inflammatory, anti-thrombotic and metabolic potential for ruvonoflast.
• Safety and efficacy data from this trial, as well as from NodThera’s previously published trial of patients with neuroinflammation³ informed the design of two large ongoing Phase 2 trials, RESOLVE-1 and RESOLVE-2, which are the largest and longest NLRP3 clinical trials to date.
  
  

“This study in patients with elevated residual inflammation establishes the potential of ruvonoflast as a selective anti-inflammatory therapy for people across the cardio-kidney-metabolic spectrum with elevated residual inflammation who remain at an increased risk for adverse cardiovascular outcomes,” said Dr. Jyothis George, M.D., Ph.D., FRCP, FACE, Chief Medical Officer of NodThera. “We look forward to the upcoming readouts of both the RESOLVE-1 and RESOLVE-2 trials, and advancing ruvonoflast into Phase 3 development to serve patients living with cardiometabolic diseases.”

About the Journal of the American College of Cardiology (JACC)

JACC is the flagship peer-reviewed journal of the American College of Cardiology and is recognized as one of the world’s leading cardiovascular journals. JACC publishes original clinical and translational research, state-of-the-art reviews, and expert consensus documents focused on advancing the prevention, diagnosis, and treatment of cardiovascular disease. Through rigorous scientific standards and global reach, JACC serves cardiologists, researchers, and healthcare professionals worldwide.

About NodThera

NodThera, the leading clinical-stage NLRP3 company developing a portfolio of potentially best-in-class brain-penetrant oral NLRP3 inhibitors to address inflammatory drivers of cardiometabolic and neurologic diseases driven by the NLRP3/IL-1/IL-6/IL-18 inflammation pathway. The Company’s lead program, ruvonoflast (NT-0796), is in Phase 2 cardiometabolic clinical trials which are expected to read out in Q3 and Q4 2026, respectively. The Company expects to commence a Phase 3 registrational study of ruvonoflast in H1 of 2027. The Company is also advancing NT-0150 for treatment of neuroinflammatory diseases and expects to release Phase 1 results in the H2 of 2026.

NodThera is backed by top-tier investors including Blue Owl Capital, Novo Holdings, F-Prime Capital, 5AM Ventures, Sofinnova Partners, Epidarex Capital, and Sanofi Ventures.

NodThera is headquartered in Boston, Massachusetts, with an R&D base in the UK. 

Learn more at www.nodthera.com or follow the Company on LinkedIn. 

Investors and Media
Argot Partners
nodthera@argotpartners.com

1 Ray KK, Clarke N, Thornton P, Miles AE, Digby Z, Davies MJ, Gorman M, Mullen B, Reader V, Magill M, Johnstone H, Ariti C, Sattar N, Marx N, Navar AM, Hernandez AF, George JT, Watt AP, Butler J, Ridker PM. Anti-inflammatory effects of oral NLRP3 inhibition with ruvonoflast among individuals at elevated cardiovascular risk. JACC. 2026. https://doi.org/10.1016/j.jacc.2026.05.014

2 Ridker PM, MacFadyen JG, Everett BM, Libby P, Thuren T, Glynn RJ; CANTOS Trial Group. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial. Lancet. 2018 Jan 27;391(10118):319-328. doi: 10.1016/S0140-6736(17)32814-3.

3 Clarke, N., Thornton, P., Reader, V., Lindsay, N., Digby, Z., Mullen, B., Gorman, M., Jacobson, E., Langdon, G., Johnstone, H., Wheeler, A. and Watt, A.P. (2025), Anti-Neuroinflammatory and Anti-Inflammatory Effects of the NLRP3 Inhibitor NT-0796 in Subjects with Parkinson's Disease. Mov Disord, 40: 2199-2208. https://doi.org/10.1002/mds.30307

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.