“The new data further substantiate the significant improvement previously demonstrated in Cohort 1 of our ongoing iNO-PF study,” said
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. Highlights from the newly presented subgroup analysis included:
- Placebo corrected benefit of 33% in MVPA for intermediate/high probability of PH
- Placebo corrected benefit of 28% in MVPA for low probability of PH
- Placebo corrected benefit of 40% in MVPA for subjects with baseline 6MWD ≤300 meters as well as 33 meters in 6MWD and 39 meter% in distance saturation product (6MWD × SpO2 Nadir)
The Company previously presented positive data from Cohort 1 that included:
- MVPA (walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04)
- 23% of subjects on INOpulse had a clinically significant improvement in MVPA, compared to 0% of subjects on placebo (placebo corrected difference of 23%)
- 39% of subjects on INOpulse had a clinically significant decline in MVPA, compared to 71% of subjects on placebo (placebo corrected difference of 32%)
- Proportion of awake time spent in MVPA improved by 38% (16% increase on INOpulse vs. 22% decrease on placebo; p=0.04)
- Overall activity improved by 12% (stable on iNOpulse vs. 12% decrease on placebo; p=0.05)
Details of the presentations are as follows:
Presentation Title: | A Subgroup analysis from the randomized, double-blind, placebo-controlled study of inhaled nitric oxide (iNO) in subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF) |
Presenter: | Steven D. Nathan, M.D., F.C.C.P., Inova Fairfax Hospital |
Date/Time: | Thursday, November 7, 2019, from 5:30 PM – 8:30 PM Central Time |
Presentation Title: | Actigraphy as a clinically meaningful endpoint to detect change after treatment with inhaled NO (30mcg/kg-IBW/hr) in patients at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis |
Presenter: | Lisa Lancaster, M.D., Vanderbilt University Medical Center |
Date/Time: | Thursday, November 7, 2019, from 5:30 PM – 8:30 PM Central Time |
About Bellerophon
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,” “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
Contacts | |
At Bellerophon: | At LifeSci Advisors: |
Fabian Tenenbaum, Chief Executive Officer | Brian Ritchie |
(908) 574-4767 | (212) 915-2578 |
britchie@lifesciadvisors.com |
Source: Bellerophon Therapeutics, Inc.