Results to be Presented in Late-Breaking Abstract as an Oral Presentation
Presentation Will Also be Published in the Highlights from CHEST Special Edition
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:
|Presentation Title:||Open label dose escalation data from the randomized, double-blind, placebo-controlled 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.
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
Fabian Tenenbaum, Chief Executive Officer
|At LifeSci Advisors:
Source: Bellerophon Therapeutics, Inc.