WARREN, N.J., Jan. 19, 2016 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that it has received EC Certification for its proprietary new, INOpulse® drug-device delivery system. This EC Certification grants CE marking on the INOpulse product, which confirms INOpulse compliance with the essential requirements of the relevant European health, safety and environment protection legislation of the European Union. This certification covers the design, development and manufacture of inhaled pulsatile nitric oxide drug delivery systems including Bellerophon’s tri-lumen cannula and application software.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics stated, “We are pleased to announce EC Certification for the new INOpulse drug-delivery system. This marks an important regulatory milestone in support of Bellerophon’s PAH Phase 3 program. The new device is significantly smaller and lighter than its predecessor, and includes an improved user interface and breath detection system. As such, it will offer greater convenience and usability to PAH patients receiving INOpulse therapy.”
INOpulse Clinical Program Focus
The focus of the Company’s INOpulse clinical program is the continued development of its nitric oxide therapy for patients with pulmonary hypertension (PH). The lead indication for INOpulse is Pulmonary Arterial Hypertension (PAH), for which FDA issued Special Protocol Assessment for the Phase 3 program and agreement was reached with European Medicines Agency (EMA) through their Scientific Advice Working Party (SAWP) process. The Phase 3 program will include 2 confirmatory trials in approximately 450 patients. The primary endpoint for each trial is Six Minute Walk Distance (6MWD), with Time to Clinical Worsening (TTCW) as a secondary endpoint, pooled across both trials. In September 2015, Bellerophon released encouraging results from the long term extension of the Company’s Phase 2 PAH clinical trial demonstrating benefit for patients on long-term oxygen therapy whose disease is progressing despite taking one or more existing PAH therapies. Bellerophon also plans to continue with Phase 2 testing in PH associated with Chronic Obstructive Pulmonary Disease (PH-COPD) and PH associated with Idiopathic Pulmonary Fibrosis (PH-IPF) for which results are anticipated by the end of 2016.
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 is currently developing three product candidates for patients with Pulmonary Hypertension under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. For more information, please visit www.bellerophon.com.
Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of our product candidates and expectations regarding the sufficiency of our cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of 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, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Amy Edmonds, Vice President
Head of Clinical Operations &
At Rx Communications Group:
Bellerophon Therapeutics LLC