“We have been extremely pleased with the rate of enrollment in Cohort 2, and are thankful for the continued support and enthusiasm from our sites. We look forward to study completion by year-end 2019,” said
Cohort 2 of iNO-PF includes 44 subjects randomized 2:1 to either iNO45 (45 mcg/kg IBW/hr) or placebo. Subjects will complete 16 weeks of blinded treatment on iNO45 vs placebo, and then continue onto open-label treatment.
- MVPA (walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04)
- 23% of subjects on iNO had a clinically significant improvement in MVPA, compared to 0% of subjects on placebo (placebo corrected difference of 23%)
- 39% of subjects on iNO had a clinically significant decline in MVPA, compared to 71% of subjects on placebo (placebo corrected difference of 32%)
- Overall activity improved by 12% (stable on iNO vs. 12% decrease on placebo; p=0.05)
- Calorie expenditure improved by 12% (6% decrease on iNO vs. 18% decrease on placebo p=0.05)
- Oxygen saturation improved by 20% (9% improvement on iNO vs. 11% deterioration on placebo)
Cohort 3 of iNO-PF is the pivotal Phase 3 study for approval, with MVPA as the primary endpoint. The study is expected to include approximately 300 subjects randomized 1:1 to active or placebo for 16 weeks of blinded treatment.
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
Source: Bellerophon Therapeutics, Inc.