Statistically Significant Improvement Demonstrated in Moderate to Vigorous Physical Activity
Bellerophon Intends to Initiate Pivotal Phase 3 in First Quarter of 2020
Company Enters Into
Bellerophon to Host Conference Call and Live Webcast Today at
Subjects in Cohort 2 of iNO-PF treated with iNO45 (45 mcg/kg IBW/hr) demonstrated statistically significant improvement in moderate to vigorous physical activity (MVPA), defined as walking, climbing stairs, yard work, and similar activities, versus placebo. The improvements in MVPA were underscored by benefits shown in other actigraphy parameters, as well as patient reported outcomes. Subjects on iNO demonstrated improvements versus placebo in the following top-line parameters:
- MVPA improved by 14 minutes per day, representing a 20% improvement (p=0.02)
- Overall activity improved by 100 counts/min, representing a 7% improvement
- St. George Respiratory Questionnaire (SGRQ) Total score improved by 3 points
- SGRQ Activity score improved by 5 points
- SGRQ Impacts score improved by 6 points
University of California, San DiegoShortness of Breath Questionnaire improved by 5 points
INOpulse was well-tolerated with no safety concerns.
“The top-line results from Cohort 2 in the iNO-PF study are exciting and highlight the potential therapeutic benefit of INOpulse,” said
“The positive top-line data from Cohort 2 of iNO-PF represent a defining milestone for our INOpulse clinical development program,” said
Cohort 2 included 44 subjects randomized 2:1 to either iNO45 or placebo for a 4 month blinded treatment period followed by an open-label extension.
Bellerophon also announced today that it has entered into an agreement for a
“We are gratified by the support and confidence in Bellerophon demonstrated through this investment by our current investors,” continued Mr. Tenenbaum. “Importantly, this capital extends our cash runway into 2021, further strengthening our cash position as we prepare to initiate pivotal Cohort 3 of iNO-PF.”
Conference Call Details
|Webcast (with slides):||http://public.viavid.com/index.php?id=137374|
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.