INOpulse Helping PH-ILD Patients Achieve and Maintain Higher Activity Levels, Trial Data Show

INOpulse can improve physical activity in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and helps them to maintain a higher level of activity, data presented at the 2019 meeting of the American College of Chest Physicians suggest.

INOpulse is a therapy that uses inhaled nitric oxide (iNO), which is a powerful vasodialator — that is, it relaxes blood vessels, causing them to widen and decreasing blood pressure. The therapy is being developed by Bellerophon.

New data come from a first patient group treated in a Phase 2 clinical trial, iNO-PF (NCT03267108), sponsored by Bellerophon. This group included 41 people with PH-ILD who were randomized to treatment with either active iNO (30 mcg/kg) or a placebo for eight weeks. Following this placebo-controlled and blinded treatment period, participants were allowed to enroll in an open-label extension (OLE), where all are being given pulsed, inhaled nitric oxide.

Data showed that 46% of patients receiving INOpulse experienced an improvement in moderate to vigorous physical activity (MVPA), compared to 15% of those on placebo.

Additionally, 62% of people on INOpulse improved in overall activity and 39% in non-sedentary activity, as compared to 15% of those on placebo in both categories. In fact, 85% of placebo-treated patients showed a decline in MVPA, overall activity, and non-sedentary activity.

“The collective data generated to date from Cohort 1 in the iNO-PF study are exciting,” Steven D. Nathan, MD, FCPP, the medical director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital, and chair of Bellerophon’s Steering Committee, said in a press release. Nathan presented the data at the CHEST annual meeting recently held in New Orleans.

“The newly presented responder analysis results are especially gratifying, with subjects on INOpulse showing benefit in moderate to vigorous physical activity, or MVPA, overall activity and non-sedentary activity, as compared to consistent and significant deterioration in the placebo group.”

Long-term results of the OLE study (average of 27 weeks) were also presented at CHEST. Nathan showed that patients treated with INOpulse in the main study continued to maintain their activity levels in the extension trial, while those who were initially given placebo and showed a decline were now showing a stabilization in activity levels.

“Subjects saw a reversal from deterioration to maintenance when switching from placebo during blinded treatment to INOpulse during open-label extension,” Nathan said, while “durability” was seen in those given iNO in both studies.

Fabian Tenenbaum, chief executive officer of Bellerophon, added: “the overall results from Cohort 1 of the iNO-PF study continue to enhance our confidence in the potential of INOpulse to offer the first treatment option for PH-ILD patients.”

According to Tenenbaum, a second patient group (cohort 2) is fully enrolled for iNO-PF, “which will assess a higher dose, as well as a longer duration of treatment, and expect to report top-line results by year-end 2019.”

PH-ILD patients in cohort 2 will be given 45 mcg/kg ideal body weight (IBW) per hour  of active iNO or placebo for a 16-week period, and then move into the open-label extension study where all will be treated with INOpulse for eight weeks.

“The data from Cohorts 1 and 2 will be used to determine the optimal dose between iNO30 and iNO45 to progress into the pivotal Phase 3 study, for which we already have agreement with the U.S. Food and Drug Administration on the use of MVPA as the primary endpoint. We anticipate initiating the Phase 3 study in the first quarter of 2020,” Tenenbaum said.