Use of Bellerophon Therapeutics’s INOpulse device led to clinically meaningful improvements in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD), according to initial data from an ongoing clinical study.
PH-ILD is associated with constriction or narrowing of pulmonary arteries, which supply the lungs with blood. This causes a decrease in cardiac output — the amount of blood the heart pumps — and right ventricular dysfunction, which is an impairment of the right side of the heart that pumps blood to the lungs.
INOpulse is a treatment that uses inhaled nitric oxide (iNO), which is a powerful vasodilator that relaxes and widens blood vessels.
A Phase 2b study, PHPF-002 (NCT03727451) is designed to evaluate the benefits of escalating iNO doses in people with PH-ILD. Specifically, the trial is assessing the treatment’s acute pulmonary hemodynamic benefit — that is, any positive results relating to how the blood flows from the heart to the lungs.
The first four study subjects, known as cohort 1, were treated sequentially. Therapy began with a dose of 30 mcg/kg (iNO30), followed by dose escalation to 45 (iNO45) and 75 (iNO75) mcg/kg.
Pulmonary hemodynamics were measured at the start of the therapy, or baseline, as well as at each sequential iNO dose. This was done using a technique called right heart catheterization — a test to determine how well the heart is pumping, and to measure blood pressure in the heart and the main blood vessels in the lungs.
The results from PHPF-002 so far have shown clinically meaningful improvements in multiple pulmonary hemodynamic factors, starting with the lowest dose of iNO30.
The dose escalation study showed that pulmonary vascular resistance — a measure of how well blood flows from the heart to lungs — improved by 29% while cardiac output improved by 16%. Meanwhile, mean pulmonary arterial pressure — a measure of blood pressure in blood vessels of the lungs — improved by 10% across doses, and oxygen saturation remained stable across doses.
Additionally, iNO treatment was well-tolerated, with no safety concerns across all doses tested.
This PHPF-002 trial is supplementary to Bellerophon’s ongoing double-blind, placebo-controlled, randomized Phase 2/3 iNO-PF study (NCT03267108). That study is assessing the safety and efficacy of INOpulse versus placebo.
Prior data showed that INOpulse can improve physical activity in PH-ILD patients, and help them to maintain a higher level of activity. Researchers believe that such improvement in physical activity is largely attributed to the acute hemodynamic benefit of the therapy now seen in cohort 1, the first group in the trial.
“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,” Roger Alvarez, DO, MPH, assistant professor at University of Miami School of Medicine, and principal investigator of the PHPF-002 study, said in a press release.
“These hemodynamic improvements confirm the therapeutic benefit of iNO30, and support the potential for further benefit on iNO45. We look forward to reporting top-line results from Cohort 2 of iNO-PF, which is evaluating iNO45 in 44 subjects, by the end of the year,” added Fabian Tenenbaum, CEO of Bellerophon.
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