– Ninerafaxstat was well tolerated and showed no impact on systemic hemodynamics in patients with stable angina and chronic coronary syndrome –

– These findings support a direct, metabolically-mediated, anti-ischemic effect of ninerafaxstat on top of existing anti-anginal agents, supporting its further development in cardiac pathologies characterized by ischemia –

BOSTON, Aug. 30, 2024 (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 data from IMPROVE-ISCHEMIA, the Phase 2 randomized, double-blind, placebo-controlled trial, evaluating the safety, tolerability and pharmacodynamics of ninerafaxstat, in patients with angina and chronic coronary syndrome, will be presented at the European Society of Cardiology (ESC) Congress, taking place in London, UK, from August 30 to September 2, 2024.

Title: A Randomized, Double-Blind, Placebo-Controlled, Mechanistic Trial on the Safety, Tolerability and Pharmacodynamics of Ninerafaxstat in Patients with Angina and Chronic Coronary Syndrome
Presenter: Antti Saraste, Professor, Internal Medicine at Heart Center, Turku University Hospital, Turku, Finland
Date: Saturday, August 31, 2024
Session Title: Pharmacotherapy in Coronary Artery Disease: From Bench to Bedside
Session Time: 13.00 to 13.50
Location: Station 3 – Research Gateway

About ninerafaxstat
Ninerafaxstat is an innovative treatment for cardiac diseases 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 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 without dose titration or monitoring required, no clinically significant drug-drug interactions and can be used on top of cardiovascular standard of care treatments.

About IMPROVE-ISCHEMIA
IMPROVE-ISCHEMIA (NCT04826172) was a randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability of ninerafaxstat in patients with stable angina and chronic coronary syndrome treated for 8-weeks on top of current antianginals. The trial further evaluated the anti-ischemic effects of ninerafaxstat through assessment of myocardial blood flow and myocardial functional response to ischemia using dobutamine stress echocardiography.

About Stable Angina
In the U.S. alone, the overall prevalence of stable angina is estimated at approximately 4% of all adults (>10 million, Tsao et al., Circulation 2023) with 500,000 new cases of angina occurring annually. Stable angina is characterized by recurrent episodes of reversible cardiac oxygen demand/supply mismatch typically resulting in pain or heaviness in the anterior chest and may be accompanied by fatigue resulting in poor quality of life. Although cardiac ischemia is a metabolic disorder disrupting cellular energetics, there are currently no approved pharmacological therapies in the U.S. which directly address this by targeting cardiomyocyte metabolism. Pharmacological treatment of angina has traditionally focused on manipulating hemodynamics to reduce cardiac oxygen demand by lowering blood pressure, cardiac contractility, and/or heart rate using beta blockers, calcium channel antagonists, and nitrates frequently in combination. However, when titrated to effect, these agents often reach a plateau of hemodynamic suppression, where adding further dose increments or therapies with a similar hemodynamic mechanism of action confers little additive symptomatic benefit, while adverse effects increase, which may limit tolerability and prevent adequate symptom relief.

About Imbria
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in Q4 2024. For additional information, please visit www.imbria.com.

Contact
Komal Joshi
Imbria Pharmaceuticals, Inc.
[email protected]

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