Bellerophon to Present New Data from Cohort 1 of Ongoing Phase 2/3 Study of INOpulse® for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease at CHEST 2019 Annual Meeting
Results to be Presented in Late-Breaking Abstract as an Oral Presentation
Presentation Will Also be Published in the Highlights from CHEST Special Edition
WARREN, N.J., Oct. 14, 2019 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that it will present additional new 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 a late-breaking oral presentation at the American College of Chest Physicians (CHEST) 2019 Annual Meeting on Wednesday, October 23, 2019, in New Orleans.
Bellerophon previously presented positive top-line data from Cohort 1 of its ongoing iNO-PF trial. Cohort 1, the first of 3 cohorts, 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. Top-line data from Cohort 1 demonstrated clinically and statistically significant improvement in moderate to vigorous physical activity, as well as other physical activity parameters measured by continuous activity monitoring (actigraphy). The Company has completed recruitment in Cohort 2, which will assess a higher dose, as well as a longer blinded treatment period. Cohort 2 includes 44 subjects randomized 2:1 to either iNO45 (45 mcg/kg IBW/hr) or placebo for 16 weeks of blinded treatment, followed by open-label treatment. Bellerophon expects to report top-line results for Cohort 2 by year-end 2019.
Details of the presentation are as follows:
Open label dose escalation data from the randomized, double-blind, placebo-controlled Presentation Title: study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis Presenter: Steven D. Nathan, M.D., F.C.C.P., Inova Fairfax Hospital Session Title: Late Breaking Abstracts Date/Time: Wednesday, October 23, 2019, from 10:45 AM – 11:45 AM Central Time
At the conference’s request, Dr. Nathan will record an abridged version of the presentation for the Highlights from CHEST, a program highlighting key topics from the meeting. The presentation will be published as a special edition immediately following the annual meeting.
About BellerophonBellerophon 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.
Forward-looking StatementsAny 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.
Contacts At Bellerophon: At LifeSci Advisors: Fabian Tenenbaum, Chief Executive Officer Brian Ritchie (908) 574-4767 (212) 915-2578 firstname.lastname@example.org