Clinical Trials

ONGOING

FORTITUDE-HCM

Imbria initiated FORTITUDE-HCM (NCT07023614), 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.

COMPLETED

IMPROVE-HCM

IMPROVE-HCM was a randomized, double-blind, placebo-controlled Phase 2a clinical trial investigating the safety and efficacy of ninerafaxstat 200 mg BID dosed for 12 weeks in 67 patients with nHCM.

The primary objective of the study was to evaluate the safety and tolerability of ninerafaxstat in patients with symptomatic nHCM and objective evidence of exercise limitation through evaluation of the incidence and severity of treatment-emergent adverse events. Efficacy evaluations included exercise responses measured by standardized cardiopulmonary exercise testing and patient-reported symptoms.

IMPROVE-DiCE

IMPROVE-DiCE (NCT04826159) was the first clinical trial utilizing multi-nuclear and state-of-the-art hyperpolarized MR spectroscopy to quantify the metabolic and energetic responses to an investigational metabolic modulator in cardiovascular disease. It was a two-part, Phase 2a clinical trial evaluating the safety, tolerability, and pharmacodynamic effects of ninerafaxstat.

Part 1 enrolled pre-HFpEF patients with type 2 diabetes and obesity and demonstrated normalization of cardiac energetics, significant reduction in cardiac steatosis and improvements to the rate of diastolic filling, an important component of heart failure.

Part 1 enrolled pre-HFpEF patients with type 2 diabetes and obesity and demonstrated normalization of cardiac energetics, significant reduction in cardiac steatosis, and improvements in the rate of diastolic filling, an important component of heart failure. The results of Part 1 were presented at the European Society of Cardiology Congress in August 2022.

Part 2 enrolled symptomatic patients with cardiometabolic HFpEF and assessed the impact of ninerafaxstat on cardiac energetics, diastolic function, functional capacity and heart failure symptoms.

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