Bellerophon Therapeutics, Inc. (Nasdaq: 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.
Presentation Details
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
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