Results to be Presented in Late-Breaking Abstract as an Oral Presentation
Company will Also Present a Corporate Overview and Update on its PH-ILD Program at Respiratory Innovation Summit
WARREN, N.J., May 13, 2019 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that it would present a late-breaking abstract with additional data from Cohort 1 of its ongoing Phase 2/3 randomized, double-blind, placebo-controlled clinical study (iNO-PF) of INOpulse® for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) as an oral presentation at the American Thoracic Society (ATS) 115th International Conference on Monday, May 20, 2019. The Company will also provide a corporate overview and an update on its PH-ILD development program during the What’s Emerging in IPF/ILD session at the Respiratory Innovation Summit (RIS) on Friday, May 17. Both conferences are being held in Dallas.
In January 2019, Bellerophon announced positive results from Cohort 1 of its ongoing iNO-PF trial. Cohort 1 included 41 subjects randomized 1:1 to either iNO 30 (30 mcg/kg IBW/hr) or placebo, for a period of 8 weeks of blinded treatment. Subjects on iNO demonstrated improvements in key parameters, including statistically significant improvements in physical activity, as measured by an autonomous wearable activity monitor (actigraphy):
- Moderate to vigorous physical activity (MVPA) (Minutes of MVPA, such as walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04).
- Overall activity improved by 12% (0% change on iNO vs. 12% decrease on placebo; p=0.05).
- NT-ProBNP improved by 27% (15% increase on iNO vs. 42% increase on placebo). NT-ProBNP is a peptide marker of right ventricular failure, with higher levels indicative of disease worsening.
- Oxygen saturation improved by 20% (9% improvement on iNO vs. 11% deterioration on placebo).
Based on these results, Bellerophon reached an agreement with the U.S. Food and Drug Administration (FDA) on the use of MVPA as the primary endpoint in the pivotal Phase 3 study. In addition, the FDA agreed with the Company’s proposal that the ongoing Phase 2b study be amended to a seamless Phase 2/3 trial, allowing Bellerophon to continue directly into the final third cohort required for approval.
Bellerophon is actively recruiting patients in Cohort 2 of its INO-PF trial, which will assess a higher dose (iNO45), as well as a longer duration of treatment to 16 weeks. The Company continues to see strong recruitment activity and support from clinical sites, and top-line data from Cohort 2 are anticipated in the second half of 2019. Bellerophon also expects to initiate Cohort 3 in the second half of 2019.
Details of the presentations are as follows:
|Presentation Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) at a Dose of 30mcg/kg-1BW/hr (iNO 30) in Subjects at Risk of Pulmonary Hypertension Associated with Pulmonary Fibrosis (PH-PF) on Long Term Oxygen Therapy|
|Presenter:||Steven D. Nathan, M.D., F.C.C.P., Inova Fairfax Hospital|
|Session Title:||B14 – Late Breaking Clinical Trials|
|Date/Time:||Monday, May 20, 2019, at 10:15 AM – 12:15 PM Eastern Time|
|Session Title:||What’s Emerging in IPF/ILD|
|Presenter:||Fabian Tenenbaum, Chief Executive Officer of Bellerophon Therapeutics|
|Date/Time:||Friday, May 17, 2019, at 4:45 PM – 5:53 PM Eastern Time|
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system. 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,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “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 Annual Report on Form 10-K and in subsequent 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.
Fabian Tenenbaum, Chief Executive Officer
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