Imbria’s IMPROVE-ISCHEMIA Trial of Ninerafaxstat Completes Enrollment

August 16, 2023—Imbria Pharmaceuticals, Inc. announced that it has completed enrollment in the IMPROVE-ISCHEMIA clinical trial of the company’s investigational therapy, ninerafaxstat, in patients with stable angina. Imbria expects to report topline results from this trial in the fourth quarter of 2023.

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

Juhani Knuuti, MD, Professor and Director of Turku PET Centre in Turku, Finland, is Chief Investigator of the IMPROVE-ISCHEMIA trial.

“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,” commented Dr. Knuuti, in Imbria’s press release. “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.”

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

According to the company, ninerafaxstat is a treatment for cardiac diseases characterized by an imbalance of energy supply and demand in the heart. Ninerafaxstat is a partial fatty acid oxidation—pFOX—inhibitor that acts to shift the heart’s preference from fatty acids toward glucose, leading to more efficient energy generation with the potential for improved cardiac function both at rest and during exercise.

Imbria currently has two additional ongoing phase 2 clinical trials with ninerafaxstat. IMPROVE-HCM is a randomized, placebo-controlled clinical trial in patients with nonobstructive hypertrophic cardiomyopathy. Topline data is expected in the fourth quarter of 2023. IMPROVE-DiCE is an open-label clinical trial currently enrolling patients with cardiometabolic heart failure with preserved ejection fraction. Interim data are also expected in the fourth quarter of 2023, advised the company.