The company’s clinical study of INOpulse is for the treatment of pulmonary hypertension associated with interstitial lung disease.
Bellerophon Therapeutics (NASDAQ:BLPH) has announced positive data from its clinical study, called PHPF-002, of INOpulse in treating pulmonary hypertension with interstitial lung disease (PH-ILD).
As quoted in the press release:
PHPF-002 is an ancillary study to the Company’s ongoing double-blind, placebo-controlled, randomized, Phase 2/3 iNO-PF study of INOpulse for the treatment of PH-ILD, for which the Company expects to report top line results for Cohort 2 by the end of the year.
The results to date from PHPF-002 have demonstrated clinically meaningful improvements in multiple pre-specified pulmonary hemodynamic parameters, starting with the lowest dose of 30 mcg/kg IBW/hr (iNO30). Dose escalation showed:
- Pulmonary vascular resistance (PVR) improved by 29% (baseline PVR was 584 dynes × sec × cm-5)
- Cardiac Output (CO) improved by 16% (baseline CO was 3.5 L/min)
- Mean Pulmonary Arterial Pressure (mPAP) improved by 10% across doses (baseline mPAP was 34.3 mmHg)
- Oxygen saturation remained stable across doses
- iNO was well-tolerated with no safety concerns across doses
“PH-ILD results in severe functional impairment and significantly reduced life expectancy. These patients suffer from constriction of the pulmonary arteries that decreases cardiac output and causes right ventricular dysfunction,” said Roger Alvarez, DO, MPH, Assistant Professor University of Miami School of Medicine, and Principal Investigator in the PHPF-002 study. “The hemodynamic improvements demonstrated by INOpulse’s targeted vasodilation are compelling and provide the potential to meaningfully increase physical activity in PH-ILD patients who have limited ability to perform even the most basic daily tasks.”