Heart Metabolics Limited, a new Irish biotechnology company is focused on the development of drugs for cardio-metabolic diseases including the treatment of hypertrophic cardiomyopathy (“HCM”).
Hypertrophic cardiomyopathy (“HCM”) is one of the most common of all hereditary heart diseases. Heart Metabolics is developing perhexiline as a new therapy for congestive heart failure symptoms in HCM. The current treatment options for severe HCM are limited, with no FDA approved drugs for these patients. On the heels of positive Phase 2 clinical results for perhexiline in HCM in the U.K., and a strong intellectual property position, the company is focusing its efforts on obtaining a Special Protocol Assessment (SPA) from the FDA in 2014 for its pivotal Phase 3 clinical trial that will commence in early 2015. The drug has orphan drug designation in the United States from the FDA and the company is seeking orphan drug designation in the EU. In addition, the company has a second drug candidate in preclinical development for an undisclosed indication of high unmet medical need.