“PH-ILD patients have limited ability to perform even the most basic daily tasks. The ability of INOpulse to improve moderate to vigorous physical activity, or MVPA, as well as other activity parameters, such as overall activity and caloric expenditure, is a significant finding,” said Dr. Nathan. “Importantly, subjects receiving iNO improved their oxygen saturation as compared to the placebo group, which saw a decrease. Subjects on open-label extension saw continued benefit on treatment, with subjects who transitioned from placebo to active treatment experiencing a change from deterioration to improvement in both MVPA and overall activity. I am excited by the meaningful improvements seen to date and look forward to the continued evaluation of this promising therapy in the clinic.”
“We continue to be extremely pleased with the collective results from Cohort 1 of the iNO-PF study, which served as the basis for an agreement with the
The top-line data reported in
- MVPA (Minutes of MVPA, such as walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04)
- Overall activity improved by 12% (stable on iNO vs. 12% decrease on placebo; p=0.05)
- NT-ProBNP improved by 27% (15% increase on iNO vs. 42% increase on placebo). NT-ProBNP is a peptide marker of right ventricular failure, with higher levels indicative of disease worsening.
- Oxygen saturation improved by 20% (9% improvement on iNO vs. 11% deterioration on placebo)
The ATS presentation included additional activity parameters that were supportive of the previously announced top-line results, as well as new data from subjects on open-label extension. Presentation highlights included:
- The 34% placebo corrected improvement in MVPA was supported by strong separation between subjects on iNO and subjects on placebo:
° 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%)
° Clinically significant improvement is >15% increase in MVPA from baseline; clinically significant decline is >15% decrease in MVPA from baseline
- Proportion of awake time spent in MVPA improved by 38% (16% increase on iNO vs. 22% decrease on placebo; p=0.04)
- Calorie expenditure improved by 12% (6% decrease on iNO vs. 18% decrease on placebo; p=0.05)
- Subjects on open-label extension demonstrated consistent improvements in MVPA and overall activity, with subjects transitioning from placebo to open-label experiencing a reversal from worsening to improving:
° Subjects on placebo had an average weekly decrease of 3 minutes per day of MVPA during blinded treatment, which reversed to an average weekly increase of 1 minute per day during open-label
° Subjects on placebo had an average weekly decrease of 22 counts per minute in overall activity during blinded treatment, which reversed to an average weekly increase of 15 counts per minute during open-label
° Subjects on active treatment remained stable for both MVPA and overall activity during blinded treatment, both of which improved during open-label, with an average weekly increase of 1 minute per week in MVPA and 15 counts per minute in overall activity
The ATS presentation and poster can be found at investors.bellerophon.com.
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
|At Bellerophon:||At LifeSci Advisors:|
|Fabian Tenenbaum, Chief Executive Officer||Brian Ritchie|
|(908) 574-4767||(212) 915-2578|
Source: Bellerophon Therapeutics, Inc.