Bellerophon Therapeutics, Inc. Announces Data from its Ongoing INOpulse® Phase 2B Clinical Trial
January 29, 2019 at 01:46 pm IST
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Bellerophon Therapeutics, Inc. 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. 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.
Bellerophon Therapeutics, Inc. is a clinical-stage therapeutics company. The Company is focused on developing products that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Companyâs focus is to develop its nitric oxide therapy for patients with pulmonary hypertension (PH) using its delivery system, INOpulse. The Companyâs INOpulse program is an extension of the technology used in hospitals to deliver continuous flow inhaled nitric oxide. INOpulse program is built on scientific and technical development for the therapeutic delivery of inhaled nitric oxide. It is also developing INOpulse for the treatment of patients with fibrotic interstitial lung disease (fILD), PH-Sarcoidosis, PH-chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension, and other pulmonary hypertension conditions. The Companyâs subsidiaries include Bellerophon BCM LLC, Bellerophon Pulse Technologies LLC and Bellerophon Services, Inc.