Positive Data Presented From Bellerophon's Preclinical Study of Bioabsorbable Cardiac Matrix (BCM) Show Reduced Ventricular Remodeling and Increased Ejection Fraction After Heart Attack
HAMPTON, N.J., May 27, 2015 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced positive results from a recent pig study evaluating the effect of its bioabsorbable cardiac matrix (BCM) product candidate on the mechanics of the heart following a heart attack. The results were presented in a late-breaking poster (Clinical Forum, no. 2013) entitled, "Intracoronary artery deployment of a bioabsorbable cardiac matrix (BCM) alginate device improves mechanics of the infarct region in pigs," at the Clinical Forum of the European Society of Cardiology's Heart Failure 2015/2nd World Congress on Acute Heart Failure, being held in Seville, Spain. The poster is available on the Company's website at www.bellerophon.com/ESC_Heart_Failure_2015.
In this preclinical study of BCM, a pig model of acute myocardial infarction (AMI) was used to test the efficacy of BCM in reducing the impact of a heart attack as measured by the volume and pumping efficiency of the heart. BCM was administered by intracoronary injection four days after the myocardial infarction (MI). The data from this test demonstrated that administration of BCM results in reduced ventricular remodeling as measured by left ventricular end systolic volume index (LVESI) and left ventricular end diastolic volume index (LVEDI) improvements over placebo of 9.5 and 7.0 mL/m2, respectively, as measured 56 days post-MI. In addition, in the study BCM increased the ejection fraction after an MI by 12% versus placebo, as measured 56 days after the MI. BCM also improved measures of contractility in surviving myocardium of the infarct zone compared to placebo.
The deployment of BCM in this preclinical study was similar to the design of the Company's ongoing 303-patient double-blind, placebo-controlled trial which completed enrollment in December 2014 and for which topline results will be available in mid-2015 following a six month evaluation period for all patients. This trial, known as PRESERVATION-1, is designed to test the value of BCM for the prevention of cardiac remodeling and subsequent congestive heart failure following a heart attack. The primary endpoint of the study is change in LVEDI versus placebo, and additional measures include LVESI and ejection fraction. Secondary endpoints for this trial are patient reported as recorded on the Kansas City Cardiomyopathy Questionnaire (KCCQ), six-minute walk distance, and time to a cardiovascular event comprising cardiovascular death or hospitalization or non-fatal heart failure. PRESERVATION-1 is a CE mark registration trial for European Union regulatory purposes and is comparable to a feasibility clinical trial in United States.
BCM is an injectable device currently undergoing a double-blind, placebo controlled trial (PRESERVATION-1) for the prevention of cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction (AMI), commonly known as a heart attack. More than 1.9 million patients in the United States and European Union suffer a heart attack each year, of which approximately 35-40% develop congestive heart failure within five years of the event. Bellerophon Therapeutics' BCM is a liquid medical device that is intended to prevent congestive heart failure after a heart attack. BCM is administered through an injection into the coronary artery, leading to the damaged area of the heart, after an AMI. The injection is made during a minimally invasive procedure called percutaneous coronary intervention (PCI), a procedure which is commonly used when opening up cardiac blood vessels in patients requiring a stent.
Once BCM is deployed, it flows into damaged heart muscle where it forms a gel which acts as a protective meshwork, or scaffold, within the wall of the heart's left ventricle. This flexible scaffold provides physical support to the heart wall and prevents further damage, while the heart heals, after the AMI. BCM is bioabsorbable and eliminated from the body after the heart heals. Bellerophon has an exclusive worldwide license to BCM from BioLineRx Ltd.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The Company has two programs in advanced clinical development. The first program, INOpulse®, is based on the Company's proprietary pulsatile nitric oxide delivery device. The Company is currently developing two product candidates under its INOpulse program: one for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in the second half of 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development. The Company's second program is bioabsorbable cardiac matrix (BCM), an injectable device for the prevention of cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction (AMI), commonly known as a heart attack. BCM is currently in a placebo-controlled clinical trial, expected to report top-line results in mid-2015, designed to support CE mark registration in the European Union and, assuming positive results, to provide the basis for an additional registration trial in the United States. Bellerophon has an exclusive worldwide license to BCM from BioLineRx Ltd. For more information, visit www.bellerophon.com.
Any statements in this press release about Bellerophon's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Any forward-looking statements represent Bellerophon's views only as of the date of this press release. Bellerophon anticipates that subsequent events and developments will cause its views to change. While Bellerophon may elect to update these forward-looking statements at some point in the future, Bellerophon specifically disclaims any obligation to do so.
CONTACT: At Bellerophon:
Manesh Naidu, Chief Business Officer
At Rx Communications Group:
Paula Schwartz (Investors)
Eric Goldman (Media)
Bellerophon Therapeutics LLC