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Imbria Pharmaceuticals Announces Initiation of Enrollment in IMPROVE-HCM, a Phase 2 Study Investigating the Safety, Tolerability, and Efficacy of IMB-1018972 (IMB-101) in Patients With Non-Obstructive Hypertrophic Cardiomyopathy

BOSTON–()–Imbria Pharmaceuticals, a clinical stage biopharmaceutical company developing novel therapies designed to enhance cellular energetics for the treatment of major forms of heart disease and specific inborn errors of metabolism, today announced that the Hypertrophic Cardiomyopathy Center at Boston-based Tufts Medical Center has randomized the first patient in the IMPROVE-HCM study, a Phase 2 study of the safety, tolerability, and efficacy of IMB-101 in patients with non-obstructive hypertrophic cardiomyopathy (HCM).

IMB-101 is a novel, investigational cardiac mitotrope in development for the treatment of cardiovascular disease. As a partial fatty acid oxidation (pFOX) inhibitor, IMB-101 is designed to shift myocardial substrate utilization in favor of glucose oxidation to generate more ATP per unit of oxygen consumed, thereby increasing the efficiency of energy generation.

“The first patient dosed in our IMPROVE-HCM study marks a significant milestone for Imbria and follows the recruitment of the first 10 patients in the IMPROVE-DiCE study as announced in June. We look forward to working closely with our sites and investigators to complete this trial,” said Jai Patel, MRCUP(UK), CMO of Imbria Pharmaceuticals.

“Patients with symptomatic non-obstructive hypertrophic cardiomyopathy represent one of the most important unmet treatment needs for this genetic heart disease. I am truly excited to be part of this important clinical trial initiative evaluating a novel drug therapy aimed at improving the lives of this subgroup of HCM patients,” said Dr. Martin S. Maron, Director of the Hypertrophic Cardiomyopathy Center at Boston-based Tufts Medical Center.

IMPROVE-HCM is a randomized, double-blind, placebo-controlled study that will assess the safety, tolerability, and efficacy of IMB-101 in patients with non-obstructive hypertrophic cardiomyopathy (HCM). This study will measure the change from baseline of peak oxygen consumption and oxygen uptake efficiency slope, measured by standardized cardiopulmonary exercise testing (CPET) in 60 non-obstructive HCM patients treated with 200 mg BID of IMB-101 over a 12-week period. Incidence and severity of treatment emergent Adverse Events (AEs), as well as incidence of treatment emergent Serious Adverse Events (SAEs) will also be examined.

Please refer to clinicaltrials.gov for additional clinical trial information.

About IMB-101

IMB-101 is a novel, investigational cardiac mitotrope in development for the treatment of cardiovascular disease. As a partial fatty acid oxidation (pFOX) inhibitor, IMB-101 is designed to shift myocardial substrate utilization in favor of glucose oxidation to generate more ATP per unit of oxygen consumed thereby increasing myocardial metabolic efficiency. IMB-101 is currently being investigated in three Phase 2 proof-of-concept studies in patients with hypertrophic cardiomyopathy, stable angina, and type 2 diabetes at risk for diabetic cardiomyopathy.

About Imbria Pharmaceuticals

Imbria Pharmaceuticals uses a deep understanding of energy metabolism to develop novel therapies designed to substantially improve the lives of patients with life-altering diseases. Our clinical stage pipeline is focused on restoring or improving the cell’s ability to produce energy in disorders where energetic impairment is a fundamental contributor, including cardiovascular disease and specific inborn errors of metabolism. Our lead program, IMB-101, is currently in Phase 2 clinical development in three indications: Hypertrophic cardiomyopathy, stable angina, and type 2 diabetes at risk for diabetic cardiomyopathy. Our pipeline also includes IMB-203, designed to address the energy deficiency in patients with rare inborn errors of mitochondrial metabolism. For additional information, please visit www.imbria.com.

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