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Bellerophen details study of inhalation device for hypertension patients

April 8, 2017

Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today released clinical data from a poster presented at the 37th Annual Meeting for the International Society for Heart and Lung Transplantation (ISHLT) in San Diego, CA on April 6th. The poster Effects of Ambulatory Inhaled Nitric Oxide on Exercise Induced Increases in Pulmonary Pressures featured data from an investigator led study of INOpulse® in patients with pulmonary arterial hypertension (PAH).

“This study reinforces existing knowledge and provides real world information that suggests pulsed inhaled nitric oxide, as delivered by the iNO pulse device, may have a role in blunting pulmonary pressures both with and without exercise in PAH patients,” said Dr. Raymond L. Benza of the Cardiovascular Institute at Allegheny General Hospital, Pittsburgh, PA and Lead Investigator in the clinical study. “PAH continues to be a life-threatening, progressive disorder, despite the availability of several approved treatments.  The use of the INOpulse therapy may allow for increases in exercise capacity and may have a role in the long term treatment of these patients.”

Study Design
This was an investigator led study conducted at the Division of Cardiology, Western University, London, ON and the Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA.

Pulmonary arterial hypertension is characterized by progressive increases in pulmonary vascular resistance (PVR) and subsequent reductions in cardiac output (CO); these changes are further exacerbated by exercise.  Inhaled nitric oxide can decrease PVR and improve CO.

The authors looked at the effects of pulsed inhaled nitric oxide (iNO) delivered by the iNO pulse device in PAH patients both before and after exercise. Ten patients were enrolled with PAH and who previously had a CardioMEMS device implanted as part of the ongoing VITA study.  The primary endpoint was a measurement of the difference in pulmonary artery pressures (PAP) and total pulmonary resistance (TPR), before and after exercise, with and without pulsed iNO.  They also measured surrogate markers of exercise such as: 6 minute walk test (6MWT) distance, O2 saturations, Borg dyspnea scale, and other RV derived parameters from the CardioMEMS device.

CardioMEMS readings were taken at 6 time points: baseline, immediately after a 6MWT, after 30 minutes rest (then started on pulsed iNO), 30 minutes after drug wash-in, immediately after repeat 6MWT and a final reading 30 minutes after drug discontinuation to ensure return to baseline.

Significant increases with exercise were seen on the following parameters: pulmonary arterial pressure (PAP) (mean PAP 7.72±1.80mmHg, p=0.002), cardiac index (CI) (0.61±0.25 L/min/m2, p=0.04), and RV stroke work index (RVSWI) (3.39±1.03 g/m2/beat, p=0.01).  Effective compliance significantly decreased (Ceff) (-1.01±0.23, p=0.002).

The effect of iNO on the “at rest” measurements signaled a consistent trend toward improvement in PAP, CI, RVSWI, TPR and Ceff.  This trend was preserved and demonstrated a blunting effect with exercise.  In comparing the absolute differences in measured characteristics in the pre/post exercise group with and without iNO, again the trend was preserved.

iNO administration did not appear to have any impact on systemic blood pressures, heart rates, or respiratory rates. No significant negative effects were recorded.

Bellerophon is currently conducting a Phase 3 trial, INOvation-1, investigating the INOpulse device in PAH.  Topline results are targeted in mid-2018 with an interim read expected around the end of 2017.  The company has reached agreement with the U.S. Food and Drug Administration (FDA) that the INOvation-1 study, together with a second confirmatory randomized withdrawal study, can together serve as the two adequate and well-controlled studies to support a New Drug Application (NDA) filing for INOpulse in PAH.


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