Actigraphy is Being Utilized to Evaluate Multiple Clinically Meaningful Activity Parameters in the Ongoing INOpulse® Phase 2b Clinical Trial for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Data to be Presented in a Poster Session at the 13th Annual Pulmonary Vascular Research Institute World Congress on Pulmonary Vascular Disease
WARREN, N.J., Jan. 28, 2019 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that data from the Company’s ongoing INOpulse® Phase 2b clinical trial (iNO-PF) for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) that supports actigraphy as a clinically meaningful endpoint will be the subject of a poster presentation at the 13th Annual Pulmonary Vascular Research Institute World Congress on Pulmonary Vascular Disease, which will take place January 31 through February 3, 2019, in Barcelona, Spain.
Actigraphy (medical wearable continuous activity monitoring) provides highly sensitive objective real-world physical activity data that correlates to patient functional abilities and health outcomes. Bellerophon is currently utilizing actigraphy to evaluate multiple clinically meaningful activity parameters in the iNO-PF study. In addition, actigraphy is currently being utilized as the primary endpoint in several pivotal clinical trials in other cardiopulmonary indications, such as heart failure and Chronic Obstructive Pulmonary Disorder.
“Evaluating real-world physical activity in patients suffering from cardiopulmonary diseases provides invaluable insight in assessing disease progression and overall patient well-being,” said James Loyd, M.D., Professor of Medicine at Vanderbilt University Medical Center, an author of the poster to be presented and a principal investigator in the iNO-PF study. “Having enrolled more than 10 patients into the iNO-PF study, including the first patient into Cohort 2, I believe that actigraphy provides clinically meaningful data sensitive to functional change following treatment with INOpulse. Based on my experience and the clinical data generated to date, I am confident that INOpulse has the unique potential to become the first therapy to treat PH-ILD, a disease with a serious unmet medical need.”
The data to be presented was generated in Cohort 1 of the iNO-PF trial, which consisted of 41 subjects who were randomized to iNO 30 (30 mcg/kg IBW/hr) vs. placebo, with a one-week run-in period, followed by an eight-week double-blinded treatment period. Statistically significant improvements in multiple clinically meaningful activity parameters were observed in the treatment arm. Subjects on pulsed inhaled nitric oxide (iNO) demonstrated an increase of 8% in moderate activity (walking, stairs, yardwork, etc.) versus a 26% decrease for subjects on placebo (p=0.04). Subjects on iNO showed no decline in their overall activity levels versus a 12% decline for subjects on placebo (p=0.05). Cohorts 2 and 3, which are ongoing, will assess higher doses, iNO 45 and iNO 75, as well as a longer 16-week treatment period.
Title: Actigraphy as a clinically meaningful endpoint to detect change after treatment with iNO (30 mcg/kg-IBW/hr) in patients at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis
Date/Time: Saturday, February 2, 2019 (6:15-7:30 PM)
Session: Moderated Poster Session
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.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,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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.
|At Bellerophon:||At LifeSci Advisors:|
|Fabian Tenenbaum, Chief Executive Officer||Brian Ritchie|
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