All Functional Areas Strengthened to Support Advancement of the Clinical Pipeline
Dublin, Ireland—March 15, 2016: Heart Metabolics Limited (Heart Metabolics), a biotechnology company focused on the development of drugs for orphan diseases including hypertrophic cardiomyopathy (HCM), today announced three key additions to the executive team – Dr. Robert Shalwitz as Chief Operating Officer, Dr. Mark Midei as Executive Director, Head of Cardiology, and Mr. Ian Howes as Chief Financial Officer.
“Bob, Mark and Ian bring proven leadership and breadth of experience to the Heart Metabolics team that will be critical as we advance our lead program, perhexiline for HCM,” said William Daly, President and Chief Executive Officer of Heart Metabolics.“ These executive appointments come on the heels of a recently completed comprehensive TQT study showing perhexiline provides protection against potentially detrimental hERG channel dysfunction that could result in cardiac arrhythmias.”
Dr. Shalwitz joins Heart Metabolics from Akebia Therapeutics, where he was co-founder and Chief Medical Officer. Prior to Akebia, Dr. Shalwitz was Medical Director for Abbott Labs where he gained approval for two New Drug Applications (Lovaza® and Neoprofen®). After Abbott, he was Vice President, Clinical Development, for Reliant Pharmaceuticals.
“I am very excited to join such a talented and experienced team and to have the opportunity to oversee the development of such an important drug as perhexiline,” said Dr. Shalwitz.
Heart Metabolics also welcomes Dr. Midei who was a founding member and Medical Director of Midatlantic Cardiovascular Associates in central Maryland. Dr. Midei has served as the principal investigator on dozens of pharmaceutical and medical device trials at all phases of development. Dr. Midei has also served as a regulatory consultant to Heart Metabolics since its inception.
“Hypertrophic Cardiomyopathy is a debilitating genetic disorder and I am very much looking forward to helping bring perhexiline to patients who have no other approved treatment options,” said Dr. Midei.
Mr. Howes comes to Heart Metabolics from Scioderm, a company developing treatments for rare pediatric diseases that was recently acquired by Amicus Therapeutics. Prior to that, Mr. Howes was Chief Financial Officer for Akebia Therapeutics.
“Heart Metabolics is an exciting opportunity to rejoin senior colleagues and friends from Akebia where we have enjoyed past success, and look forward to potentially replicating that success with a very promising pipeline in cardio-metabolic disease,” said Mr. Howes.
About Hypertrophic Cardiomyopathy (HCM)
HCM is one of the most common of all hereditary heart diseases and the leading cause of sudden cardiac death in young adults. HCM is a genetic defect of heart muscle that occurs due to deletions in genes that encode key contractile proteins in the heart. As a result, there is enlargement of the heart muscle that causes abnormal cardiac energetics. In later stages of the disease, patients develop debilitating and unrelenting symptoms of heart failure. There are more than 120,000 people in the U.S. with HCM who suffer from moderate-to-severe heart failure symptoms. The current treatment options for patients with this disease are limited, with no FDA-approved drugs.
Perhexiline is a carnitine palmitoyl-acyltransferase (CPT) inhibitor being developed by Heart Metabolics to treat symptoms in patients with HCM. Perhexiline blocks the uptake and metabolism of fatty acids by the heart, causing the heart to ‘switch’ to glucose as a fuel source. This results in improved myocardial energetic, reducing or even normalizing the energy imbalance created by the genetic defect that defines HCM. In addition, perhexiline has multiple ion channel effects that limit the potential for destabilizing ventricular arrhythmias. It is believed that perhexiline treatment of symptomatic patients with HCM may delay, prevent or even reverse progression of disease. In a Phase 2 clinical trial, perhexiline significantly improved cardiac energetic status (myocardial phosphocreatine:ATP ratio), LV diastolic filling at rest and during exercise, peak oxygen consumption, symptoms, and quality of life.
About Heart Metabolics
Heart Metabolics Limited is a biopharmaceutical company developing new treatments for orphan disease including cardio-metabolic diseases. The Company has obtained an Orphan Drug Designation in the US for the use of perhexiline to treat HCM patients with moderate-to-severe symptoms of heart failure. In addition, Heart Metabolics Limited has reached agreement with FDA on a Special Protocol Assessment for a single, pivotal Phase 3 trial in about 350 HCM patients. Headquartered in Dublin, Ireland, and founded in 2014, Heart Metabolics Limited is funded by venBio Partners, Seroba Life Sciences, Brandon Capital Partners (on behalf of AustralianSuper) and AshHill Biomedical. More information is available at www.heartmetabolics.com.
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