Capricor Therapeutics Completes Enrollment of Phase II Clinical Trial for Cenderitide to Treat Heart Failure

Capricor Therapeutics, Inc.

, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has completed enrollment of its first Phase II clinical trial of Cenderitide in ambulatory heart failure patients. Cenderitide is in development for the outpatient treatment of patients following an acute admission for heart failure, as well as other potential indications. The trial completed enrollment of 14 patients. Patients received up to eight consecutive days of increasing doses of Cenderitide by continuous subcutaneous infusion using Insulet's OmniPod® drug delivery system. The trial assessed the safety, tolerability, pharmacokinetic profile and pharmacodynamic response to increasing dose levels of open-label Cenderitide administered in a stepwise fashion, with each patient receiving the entire range of doses. "This Phase II trial is an important step in our clinical development program aimed at treating heart failure patients on an outpatient basis," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "Given the enormous unmet clinical need and heart failure being responsible for over 1 million hospital admissions annually and the staggering re-admission rates for these patients, the goal of this trial is to develop the potential use of Cenderitide as a therapy for patients with clinically advanced heart failure. We believe that, if approved, Cenderitide administered via a patch pump delivery system such as the OmniPod® drug delivery system could keep patients out of the hospital and potentially lower overall costs on the healthcare system. Cenderitide is a dual receptor natriuretic peptide and recent positive results in Novartis' PARADIGM-HF trial have shown that the mechanism of action of their ARNI (angiotensin receptor neprilysin inhibitor) can raise the level of endogenous natriuretic peptides by preventing their enzymatic breakdown in chronic heart failure patients. We look forward to reporting on top line data from this trial during the second half of 2015 and announcing further clinical development plans in the coming months." Heart Failure According to the American Heart Association, heart failure is the leading cause of hospitalization among adults older than 65 years of age in the United States and is responsible for over 1 million hospital admissions annually. Among those patients that have been admitted, approximately 24% are re-hospitalized within one month, and 50% are re-hospitalized within six months. Additionally, the Affordable Care Act may not allow Medicare payments for heart failure re-hospitalizations within 30 days.