Imbria Pharmaceuticals announces enrolment of the first 10 patients in IMPROVE-DiCE, an exploratory Phase 2 study investigating the impact of IMB-1018972 on cardiac energetics, metabolism and function in patients with type 2 diabetes
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 first 10 (ten) patients were dosed in the IMPROVE-DiCE Phase 2a, open-label study of IMB-1018972 (IMB-101) in patients with Type 2 diabetes at risk of diabetic cardiomyopathy.
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 10 patients dosed in our IMPROVE-DiCE study marks a significant milestone for Imbria and for patients that may benefit from a novel metabolic modulator designed to improve cardiac efficiency and function through shifting substrate metabolism towards more oxygen-efficient pathways for ATP generation,” said Anne Prener, M.D., Ph.D., President and CEO of Imbria Pharmaceuticals. “We look forward to sharing initial results from IMPROVE-DiCE later in the year as well as report on the progress of our other two phase 2 studies in stable angina and non-obstructive hypertrophic cardiomyopathy.”
IMPROVE-DiCE is a pharmacodynamic study that evaluates the impact of IMB-101 on cardiac energetic reserve at rest and during conditions of stress, as well as the safety and tolerability of IMB-101 in up to 25 patients with Type 2 diabetes. The primary outcome of the study is based on the change in the myocardial phosphocreatine/adenosine triphosphate (PCr/ATP) ratio, a measure of cardiac energetic reserve, by 31P-magnetic resonance spectroscopy (MRS) at rest and during dobutamine stress, at baseline and following 200 mg BID of IMB-101 over a 4 to 8-week treatment period. In addition, the study utilizes hyperpolarized [1-13C] pyruvate MRS cardiac metabolic imaging in a subset of patients to evaluate the impact of IMB-101 on the flux through mitochondrial pyruvate dehydrogenase (PDH), a measure of the coupling between glycolysis and glucose oxidation. The study is conducted at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Radcliffe Department of Medicine at the University of Oxford, UK and the study team, consisting of Dr. Moritz Hundertmark and Professor Damian Tyler, is led by Professor Oliver Rider.
Please refer to www.clinicaltrials.gov for additional clinical trial information (NCT04826159).
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.