Imbria Pharmaceuticals to Present Results from Phase 2 IMPROVE-DiCE Trial of Ninerafaxstat in Patients with Cardiometabolic HFpEF at the American College of Cardiology Annual Scientific Session & Expo (ACC.25)

/EIN News/ -- BOSTON, Mass., March 17, 2025 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and functional capacity by enhancing cellular energetics, today announced that the results from the Phase 2 IMPROVE-DiCE clinical trial, evaluating ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation (pFOX) inhibitor, in symptomatic patients with cardiometabolic heart failure with preserved ejection fraction (HFpEF), will be presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25), taking place in Chicago, IL, from March 29-31, 2025.  

Title: Effects of Ninerafaxstat on Myocardial Energetics, Exercise Capacity, and Cardiac Function, in Heart Failure with Preserved Ejection Fraction, Type 2 Diabetes and Obesity – A Phase 2A Clinical Trial
Presenter: Sarah Birkhoelzer, MD, MRCP(UK) Clinical Research Fellow, University of Oxford Centre for Clinical Magnetic Resonance Research, Oxford, United Kingdom 
Date: Saturday, March 29, 2025
Session Title: Innovations and Insights in Heart Failure With Preserved Ejection Fraction: Emerging Therapies, Biomarkers and Mechanistic Studies
Session Time: 9.30 – 11.30am CT
Presentation Time: 9:30 – 9:37am CT
Location: Moderated Poster Theater 5

About ninerafaxstat
Ninerafaxstat is an innovative treatment for cardiac disorders characterized by an imbalance of energy supply and demand in the heart. To maintain normal contractile function, the heart requires substantial amounts of energy, which is produced primarily by the mitochondria in the form of adenosine triphosphate (ATP). The heart normally uses two main fuels for energy generation: fatty acids and glucose. Ninerafaxstat, a partial fatty acid oxidation (pFOX) inhibitor, acts to shift the heart's preference from fatty acids towards glucose. This shift in metabolism leads to more efficient mitochondrial energy generation with the potential for improved cardiac function both at rest and during exercise. Ninerafaxstat is a simple orally administered compound with no dose titration or monitoring required, no clinically significant drug-drug interactions and can be used on top of standard of care cardiovascular treatments.

About IMPROVE-DiCE
IMPROVE-DiCE is the first clinical trial utilizing multi-nuclear spectroscopy, including state-of-the-art hyperpolarized MR spectroscopy, and MRI to quantify the cardiac energetic, metabolic and functional responses to an investigational metabolic modulator in cardiovascular disease. It is a two-part, Phase 2 clinical trial evaluating the safety, tolerability and pharmacodynamic effects of ninerafaxstat. Part 1 enrolled pre-HFpEF patients with type 2 diabetes and obesity and demonstrated normalization of cardiac energetics, significant reduction in cardiac steatosis and improvements in left ventricular diastolic filling rate, an important component of heart failure. The results of Part 1 were presented at the European Society of Cardiology Congress in August 2022. Part 2 of IMPROVE-DiCE enrolled symptomatic patients with cardiometabolic HFpEF and assessed the impact of ninerafaxstat on cardiac energetics, cardiac reserve function, exercise capacity and heart failure symptoms. The trial was conducted at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Radcliffe Department of Medicine at the University of Oxford, UK and was led by Professor Oliver Rider. For more information, please visit www.clinicaltrials.gov (Identifier: NCT04826159).

About heart failure with preserved ejection fraction (HFpEF)
Over half of all patients with heart failure have preserved ejection fraction, a clinical syndrome characterized by an inability of the heart to pump blood adequately to the body without pathological increases in filling pressures at rest or during exertion. As with other forms of heart failure, HFpEF is associated with cardiac energy deficiency resulting from impaired mitochondrial energy generation. This leads to impaired cardiac functional reserve on exertion and is associated with exercise-induced pulmonary congestion, resulting in hallmark heart failure symptoms of exertional breathlessness, fatigue, and markedly reduced exercise capacity leading to severe impairment in quality of life. Despite being associated with severe morbidity and mortality, HFpEF has few evidence-based therapies. Within the clinical syndrome of HFpEF, the cardiometabolic HFpEF phenotype, in which chronic cardiometabolic stress resulting from type 2 diabetes and obesity are key drivers of heart failure pathophysiology, is rapidly emerging as the most prevalent form.

About Imbria
Imbria is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical pipeline is focused on restoring or improving the cell’s ability to produce energy in cardiometabolic disorders where energetic impairment is a fundamental contributor to disease pathogenesis, symptoms and functional deficits. The lead product candidate, ninerafaxstat, has completed multiple Phase 2 clinical trials in three indications: non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and HFpEF. In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. For additional information, please visit www.imbria.com. 

Contact
Komal Joshi
Imbria Pharmaceuticals, Inc.
kjoshi@imbria.com