Patients Treated with INOpulse® Demonstrated Improved Physical Activity Compared to Placebo
Live Webinar with Study Investigators on
“As the first randomized, placebo-controlled study to assess the therapeutic benefits of nitric oxide in patients with pulmonary fibrosis, I’m pleased to participate in the
Cohort 1 of the iNO-PF Study was designed as a Phase 2b study to explore several endpoints and included 41 patients that were randomized 1:1 to receive either placebo or iNO30. Following eight weeks of therapy, patients treated with iNO30 demonstrated clinically and statistically significant benefits in moderate to vigorous physical activity (p=0.04) and overall activity (p=0.05). The benefits in activity levels were supported by improvements in oxygen saturation and NT-proBNP, a peptide marker of right ventricular failure, with higher levels indicative of disease worsening. The iNO30 dose was safe and well-tolerated. More recently, the Company completed Cohort 2, which assessed a higher iNO45 (45 mcg/kg IBW/hr) dose and verified the results demonstrated in Cohort 1 and is preparing to initiate its pivotal Phase 3 Cohort in a 300 patient placebo-controlled trial.
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.
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Source: Bellerophon Therapeutics, Inc.