WARREN, N.J., May 16, 2018 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that it will present the previously reported top-line results from its Phase 2 study evaluating the use of INOpulse® in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) at the American Thoracic Society (ATS) 114th International Conference, on Monday, May 21, 2018, in San Diego, CA.
This Phase 2 study (n=10) was designed to assess the acute effect of pulsed inhaled nitric oxide (iNO) on targeted vasodilation and the chronic effect (4 weeks) of iNO on hemodynamics and exercise capacity.
Key Study Results
- All patients demonstrated acute increases in blood vessel volumes following iNO treatment (+4.2%, p=0.03).
- Functional Respiratory Imaging analyses demonstrated regional dilatation of blood vessels in the lungs following acute pulsed iNO treatment with a significant association (p<0.01) between ventilation and vasodilation during iNO therapy, suggesting that regions with better ventilation experience more vasodilation.
- Patients who completed 4 weeks of iNO therapy had reductions in pulmonary arterial pressure (-19.9%, p=0.02) and had on average a 50.4±54.4 meter increase in 6MWD (p=0.04).
- The therapy was well-tolerated in all patients with no safety concerns.
“The co-morbidity of pulmonary hypertension in COPD greatly reduces patient quality of life and expected survival. There are currently no approved treatments for this serious condition, resulting in a large and profound unmet clinical need,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon Therapeutics. “We are pleased to present the positive results of our Phase 2 study at ATS, which demonstrate the potential for pulsed iNO therapy to improve pulmonary hemodynamics and exercise capacity in PH-COPD patients. Based on INOpulse’s ability to provide targeted vasodilation, as well as improve ventilation-perfusion matching, we believe it could fill the treatment void as the first approved therapy in PH-COPD. We look forward to continuing to progress INOpulse in this serious medical condition and recently reached agreement with the FDA on the design of our next Phase 2b study in our PH-COPD development program.”
ATS Poster Presentation Details
|Title:||Pulsed inhaled nitric oxide (NO) improves exercise tolerance in severe chronic obstructive pulmonary disease (COPD) patients with pulmonary hypertension (PH)|
|Date:||Monday, May 21|
|Time:||2:15pm - 4:15pm Pacific Time|
|Session:||B102 – Clinical Trials and Studies in COPD|
COPD is a common, potentially life-altering disease with a diagnosed prevalence greater than 12 million in the U.S. Approximately 25-30% of COPD patients have associated pulmonary hypertension. Although there are multiple therapies indicated for the treatment of COPD, there are no approved therapies for the treatment of PH associated with COPD.
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 program, a proprietary pulsatile nitric oxide delivery system. The first is for the treatment of PAH, for which the Company has commenced Phase 3 clinical trials. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD), both of which are in Phase 2 development. For more information, please visit www.bellerophon.com.
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.
|At Bellerophon:||At LifeSci Advisors:|
|Fabian Tenenbaum, Chief Executive Officer||Brian Ritchie|
|(908) 574-4767||(212) 915-2578|