News | Cardiovascular Clinical Studies | September 08, 2023

Imbria Pharmaceuticals Completes Enrollment in the Phase 2 IMPROVE-ISCHEMIA Clinical Trial of Ninerafaxstat in Patients with Stable Angina

Additional Phase 2 data read-outs expected in 4Q 2023, including topline from the IMPROVE-HCM in non-obstructive hypertrophic cardiomyopathy and interim data from IMPROVE-DiCE in cardiometabolic heart failure with preserved ejection fraction (HFpEF) 

MPROVE-ISCHEMIA, a randomized, placebo-controlled trial, with topline data expected in 4Q 2023

September 8, 2023 — Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company dedicated to developing innovative therapies designed to improve patient symptoms and function by enhancing cellular energetics, today announced that it has completed enrollment in the IMPROVE-ISCHEMIA Phase 2 placebo-controlled clinical trial of the investigational therapy, ninerafaxstat, in patients with stable angina. Imbria expects to report topline results from this trial in the fourth quarter of 2023. 

“The randomized, placebo-controlled IMPROVE-ISCHEMIA trial will provide detailed insights into the anti-ischemic effects of ninerafaxstat in symptomatic patients with chronic coronary syndromes, including the burden of angina," said Juhani Knuuti, M.D., Ph.D., Professor and Director of Turku PET Centre in Turku, Finland and chief investigator of the IMPROVE-ISCHEMIA trial. “Given the large projected future increases in the prevalence of ischemic heart disease and the limited level of therapeutic innovation, there is a pressing need to address the high symptomatic burden of angina with novel effective oral therapies.” 

“Ninerafaxstat has a unique mode of action that is complementary to the current standard of care, such as beta blockers and calcium channel blockers. This could give physicians and patients an additional option to control angina symptoms without adversely impacting hemodynamics,” said Jai Patel, MRCP (U.K.), chief medical officer of Imbria. “We look forward to sharing topline data from the trial in the fourth quarter of this year.” 

Imbria currently has two additional ongoing Phase 2 clinical trials with ninerafaxstat: IMPROVE-HCM, a randomized, placebo-controlled clinical trial in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) with topline data expected in the fourth quarter of 2023, and IMPROVE-DiCE, an open label clinical trial, which is currently enrolling patients with cardiometabolic heart failure with preserved ejection fraction (HFpEF) with interim data also expected in the fourth quarter of 2023. 

About IMPROVE-ISCHEMIA 

IMPROVE-ISCHEMIA is a randomized, double-blinded, placebo-controlled, Phase 2 trial evaluating the safety, anti-ischemic and anti-anginal effects of ninerafaxstat administered for 8 weeks in patients with stable angina. 

About Stable Angina 

Stable angina is characterized by recurrent episodes of reversible cardiac oxygen demand/supply mismatch typically resulting in pain or heaviness in the anterior chest, epigastrium, neck, lower jaw, shoulder and/or either arm. In some patients, breathlessness may be the only symptom of angina, or it may be accompanied by fatigue, faintness, nausea, and restlessness resulting in poor quality of life. Stable angina is usually precipitated by physical exertion, and may be triggered by cold weather, emotional stress or after a heavy meal. 

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. 

Angina may, in a minority of patients, be due to obstructive epicardial coronary artery disease. In such cases invasive revascularization procedures such as percutaneous coronary intervention or coronary artery bypass surgery may improve symptoms, however within 5 years over half of patients develop recurrent angina or anginal equivalent symptoms (Stone et al., J Am Coll Cardiol 2023). In contrast, most patients with stable angina have ischemia due to non-obstructive causes, such as coronary microcirculatory dysfunction, which are not amenable to coronary revascularization, with multiple mechanisms co-existing in some patients. 

Traditionally, pharmacological treatment of angina has 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 agents 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. 

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 the cardiomyocyte. Such an approach may have the potential for synergy with existing hemodynamic approaches across a breadth of ischemic mechanisms to achieve optimal relief of angina, maximize patient function and improve quality of life. 

For more information: www.imbria.com 

 

Related content: 

Imbria Enrolls First Patient in the Phase 2 IMPROVE-DiCE Clinical Trial Evaluating Ninerafaxstat in Patients with Heart Failure with Preserved Ejection Fraction 

Ninerafaxstat Showcased at the 19th Annual Global Cardio Vascular Clinical Trialists (CVCT) Forum with Focus on the Potential in Non-obstructive Hypertrophic Cardiomyopathy 

Positive Data Presented at HFSA Annual Meeting Demonstrate Effects of Oral Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) 

Penn Study Identifies New Prognostic Biomarker for Heart Failure 


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