Headquarters: Warren Township, NJ
Founded: 2009
bellerophon.com
Bellerophon Therapeutics announces positive top line data from a Phase 2 clinical trial evaluating INOpulse in patients with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease
The Phase 2 study was designed to assess the acute effect of pulsed inhaled nitric oxide (iNO) on targeted vasodilation and the chronic effect (4 weeks) of iNO on hemodynamics and exercise capacity. The study enrolled 10 subjects and used a dose of 30 mcg/kg IBW/hr (iNO 30).
- The acute results showed a statistically significant increase (average 4.2%) in blood vessel volume on iNO compared to baseline (p=0.03), and a statistically significant correlation in Ventilation-Vasodilation (p=0.01), indicating targeted delivery to the well-ventilated alveoli. The chronic results demonstrated statistically significant and clinically meaningful increases in six-minute walking distance (6MWD) at both 2 weeks and 4 weeks (+50.7m; p=0.04), as compared to baseline. In addition, the study demonstrated a statistically significant and clinically meaningful decrease of 19.9% in systolic pulmonary arterial pressure (sPAP) at 4 weeks (p=0.02), as compared to baseline. The therapy was well tolerated with no related safety concerns.
In addition to PH-COPD, Bellerophon is currently conducting a Phase 3 trial for INOpulse for the treatment of pulmonary arterial hypertension (PAH), with interim and top-line data expected in 2018, and recently completed a Phase 2 clinical trial that investigated INOpulse in idiopathic pulmonary fibrosis patients with pulmonary hypertension (PH-IPF). The results of the PH-IPF trial were recently presented at the American Thoracic Society meeting and the next step in this program will be to conduct a larger Phase 2b study to inform the design of a pivotal registration trial.
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Bellerophon Therapeutics, Inc. is a clinical-stage therapeutics company. The Company is focused on developing products at the intersection of drugs and devices that address medical needs in the treatment of cardiopulmonary diseases. The Company is focused on the development of its nitric oxide therapy for patients with pulmonary hypertension (PH), using its delivery system, INOpulse, with pulmonary arterial hypertension (PAH) as the lead indication. Its INOpulse device has a mechanism that delivers brief, targeted pulses of nitric oxide timed to occur at the beginning of a breath for delivery to the alveoli of the lungs, which minimizes the amount of drug required for treatment. The Company's second program, BCM, is a medical device focused to prevent congestive heart failure following a ST Segment Elevation Myocardial Infarction (STEMI), which is a type of severe heart attack. The Company's BCM is in PRESERVATION I clinical trial.
Key stats and ratios
| Q2 (Jun '17) | 2016 | |
| Net profit margin | - | - |
| Operating margin | - | - |
| EBITD margin | - | - |
| Return on average assets | -65.52% | -69.93% |
| Return on average equity | -242510.60% | -98.55% |
| Employees | 22 |
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