-- Trial expected to commence in third quarter; Results to be reported by year end 2016 --
-- Previous data supporting testing long-term benefits of pulsed inhaled nitric oxide (iNO) reported in peer-reviewed
International Journal of COPD --
WARREN, N.J., July 25, 2016 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics
company, today announced it has received health authority approval in Belgium to commence a Phase 2 trial for INOpulse, its
patented and proprietary pulsatile nitric oxide [NO] delivery device, to treat pulmonary hypertension in chronic obstructive
pulmonary disease, or PH-COPD. This follows results from the Company’s Phase 2a study and proof of mechanism work, which indicated
that INOpulse could be both safe and effective in PH-COPD. Bellerophon expects to enroll the first patient in the third quarter of
2016 with results of the trial expected before year end.
Approximately 12 million people in the United States suffer from COPD of which approximately 700,000 are PH-COPD patients.
Severe COPD is often associated with secondary pulmonary hypertension, which worsens its prognosis, is associated with high
hospitalization rates, impaired exercise capacity and carries with it a median life expectancy of four years. Earlier Phase 2a data
showed that in an acute setting, Bellerophon’s INOpulse safely reduced PH for COPD patients and increased blood volume in the
vessels within the lung.
Trial Protocol
The Phase 2 study of INOpulse for PH-COPD is designed to demonstrate the potential benefit of INOpulse on exercise capacity for
patients suffering from PH-COPD and will enroll 10 COPD patients with PH on LTOT. The trial is an open-label study of iNO 30 mcg/kg
IBW (Ideal Body Weight)/hour for four weeks with a follow up visit two weeks after discontinuation of iNO. After four weeks
of treatment, patients’ vasodilation in pulmonary arteries will be measured by high resolution CT scanning (HRCT), with a key
secondary endpoint of 6MWD at four weeks.
“This study builds on the results of earlier work by the Vonbank group in Austria, our own Phase 2a acute dose ranging study as
well as the results of a trial conducted in the Department of Respiratory Medicine at the University Hospital Antwerp, by Professor
Wilfried De Backer and Bellerophon, published in the peer-reviewed International Journal of COPD (Hajian et al., Pulmonary
vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension, International Journal of
COPD, 2016, 11:1533-1541),” stated Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics.
“The prognosis of COPD patients with severe PH is very poor and there is currently no approved therapy to treat this condition.
We look forward to developing a therapy for this serious unmet medical need and reporting results by year end 2016,” concluded Mr.
Peacock.
About Bellerophon
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 diseases. The
Company is currently developing three product candidates under its INOpulse platform, a proprietary pulsatile nitric oxide delivery
system. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3
clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary
disease (PH-COPD), which is in Phase 2 development and the third candidate is for the treatment of pulmonary hypertension
associated with Idiopathic Pulmonary Fibrosis (PH-IPF). The Company’s plans also call for the completion of further work on the use
of INOpulse to treat PH-COPD and PH-IPF during 2016. For more information, please visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about
the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and
expectations regarding the sufficiency of the Company’s 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 or interim 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, the FDA’s substantial discretion in the approval process, 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 the Company’s most recent filings with the Securities and Exchange Commission. In
addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this
release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically
disclaims any obligation to update any forward-looking statements included in this press release.
Contacts At Bellerophon: Fabian Tenenbaum, Chief Financial Officer (908) 574-4767 At Rx Communications Group: Melody Carey (917) 322-2571
