The vasodilator INOpulse increased physical activity and helped maintain higher levels of exercise in people at risk of pulmonary hypertension (PH) associated with pulmonary fibrosis (PH-PF), preliminary results from a Phase 2 trial show.
The results were presented in two posters at the Pulmonary Fibrosis Foundation Summit 2019, held Nov. 7-9 in San Antonio, Texas.
The posters were titled: “A Subgroup analysis from the randomized, double-blind, placebo-controlled study of inhaled nitric oxide (iNO) in subjects at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF),” and “Actigraphy as a clinically meaningful endpoint to detect change after treatment with inhaled NO (30mcg/kg-IBW/hr) in patients at risk of Pulmonary Hypertension associated with Pulmonary Fibrosis.”
INOpulse, being developed by Bellerophon Therapeutics, is a form of inhaled nitric oxide, a potent vasodilator — it relaxes the blood vessels, leading to a reduction in blood pressure — shown to increase the levels of physical capacity in people with PH.
The Phase 2, double-blind, placebo-controlled iNO-PF trial (NCT03267108) is testing the effect of different dosages of INOpulse in three groups of people diagnosed with PF who are at risk of developing PH.
The results presented at the PFF Summit correspond to the first group of the study, which included 41 participants, 23 of whom received 30 mcg/kg INOpulse for eight weeks. The remaining participants received a placebo. Following this period, all participants could enroll in an open-label extension study to continue or start treatment with inhaled nitric oxide.
The results showed that INOpulse treatment increased moderate-to-vigorous physical activity (MVPA) by 33% in people with an intermediate or high risk of PH, and by 28% in those with low risk of PH when compared with the placebo group.
The participants who received INOpulse could spend significantly more time performing physical tasks than those who received a placebo.
“In this analysis, INOpulse demonstrated a consistent and clinically meaningful benefit in MVPA across both low and intermediate/high probability of pulmonary hypertension groups,” Tenenbaum added.
Treatment with nitric oxide also led to significantly better results in the 6-minute walk distance (6MWD), a test assessing exercise capacity, in participants who walked less than 300 meters before starting treatment. The INOpulse-treated group showed results 40% better in MVPA than those of the placebo group.
“The improvements in MVPA, 6-minute walk distance (6MWD), and distance saturation product in the group with reduced exercise capacity were especially encouraging as it directly addresses the physical limitations that critically impact the overall quality of life in this patient population,” Tenenbaum said.
Further, the INOpulse treatment was found to be safe and tolerated well by the participants.
“Results of Cohort 1 of the iNO-PF study demonstrated clinically and statistically meaningful benefit in multiple activity parameters over eight weeks of iNO treatment,” the researchers said. “iNO was well-tolerated with no safety concerns.”
Based on the results, Tenenbaum concluded that “the collective data from Cohort 1 support the potential for INOpulse to become the first approved therapy to treat patients with PH-ILD.”
“We look forward to reporting top-line results from Cohort 2 by the end of the year,” he said.
The trial is recruiting participants in 18 U.S. states. For more information, go here.