Imbria Pharmaceuticals Partners with Hypertrophic Cardiomyopathy Association to Support FORTITUDE-HCM Trial Evaluating Ninerafaxstat for Non-Obstructive Hypertrophic Cardiomyopathy

Partnership further supports trial recruitment; FORTITUDE-HCM to be highlighted at upcoming HCMA Annual Patient Meeting

Enrollment underway for the global, multicenter, double-blind Phase 2b trial assessing efficacy and safety of ninerafaxstat in patients with symptomatic non-obstructive HCM

BOSTON, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., (“Imbria”), a clinical-stage company developing transformational cardiovascular disease therapeutics, today announced a partnership with the Hypertrophic Cardiomyopathy Association (“HCMA”), the leading advocacy group representing patients and families affected by hypertrophic cardiomyopathy. The partnership will accelerate patient recruitment and engagement in the ongoing FORTITUDE-HCM study, a Phase 2b clinical trial evaluating ninerafaxstat in symptomatic non-obstructive hypertrophic cardiomyopathy (“nHCM”), a debilitating disease with no currently approved treatments. Ninerafaxstat is a novel investigational therapy designed to optimize mitochondrial energy production in heart muscle cells without adverse impact on left ventricular ejection fraction, heart rate, or blood pressure.

HCMA will support trial recruitment by educating the HCM community about the FORTITUDE-HCM study. This includes promoting awareness through its outreach programs, conferences, patient communications, and surveys, to help connect patients and clinicians with trial information and enrollment resources. The FORTITUDE-HCM study will also be highlighted at the upcoming HCMA Annual Patient Meeting on October 18, 2025, of which Imbria is a sponsor.

“Every step forward in clinical research brings us closer to improving the lives of those living with nHCM,” said Lisa Salberg, Founder and CEO, HCMA. “By supporting patient recruitment for FORTITUDE-HCM and spotlighting this collaboration at our annual meeting, we aim to increase awareness of this potential treatment and connect patients and families with meaningful opportunities to advance research and improve care.”

“Initiating the FORTITUDE-HCM trial to evaluate ninerafaxstat for nHCM represents a major milestone for Imbria and further validates our commitment to patients and families affected by this disease,” said Alvin Shih, MD, Imbria’s Chief Executive Officer. “We are proud supporters of the HCMA and its dedicated work on behalf of this patient community, and we look forward to working with Lisa and her team to accelerate the development of therapies for nHCM.”

About FORTITUDE-HCM
Initiated in 2025, FORTITUDE-HCM (NCT07023614) is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b clinical trial enrolling approximately 165 patients with nHCM. Participants will receive ninerafaxstat 200 mg BID or placebo. The primary endpoint is change from baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (“KCCQ-CSS”). Secondary endpoints include additional measurements of symptoms from the KCCQ and measurements of functional capacity from standardized cardiopulmonary exercise testing (CPET). Enrollment for FORTITUDE-HCM is underway in the United States. Additional sites in the European Union and the United Kingdom are anticipated to begin enrolling by the end of 2025.

About Ninerafaxstat
Ninerafaxstat is an innovative treatment under development 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.

About Non-Obstructive Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiac disease, characterized by the abnormal thickening of the heart muscle, which can lead to various complications. HCM is most often diagnosed in middle age, and symptoms can vary widely. In non-obstructive HCM (nHCM), the heart muscle becomes abnormally thickened, impairing the blood flow out of the heart, leading to the heart muscle working harder to pump blood to the body. Patients with nHCM experience a high burden of symptoms of heart failure and are at risk for adverse disease complications, including irregular heart rhythms, yet there are no approved treatments available. It is estimated that nHCM affects one-third of all people with HCM, approximately 250,000-400,000 patients in the United States.

About Imbria
Imbria Pharmaceuticals is a clinical-stage company developing transformational cardiovascular disease therapeutics by targeting cardiac energy metabolism. The company’s focus is ninerafaxstat, a differentiated, first-in-class cardiovascular therapy. A pipeline-in-a-pill, it has broad potential utility by improving cardiac energetics without adverse effects on heart rate, rhythm, ejection fraction, or blood pressure. The recently initiated FORTITUDE-HCM (NCT07023614), Phase 2b clinical trial is addressing nonobstructive hypertrophic cardiomyopathy (nHCM), a debilitating disease with no currently approved treatments. Phase 2a data showed compelling safety and efficacy potential in an approvable endpoint. Plans are underway to initiate a Phase 2b clinical trial in heart failure with preserved ejection fraction (HFpEF), a large and growing unmet need. Based in the Boston area, Imbria is backed by a leading syndicate of investors, including RA Capital, SV Health Investors, Deep Track Capital, Catalio Capital Management, AN Ventures, and Cytokinetics. For more, visit www.imbria.com.

Media Contact:
Gina Mangiaracina
6 Degrees
(917) 797-7904
gmangiaracina@6degreespr.com

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