Phase 3 INOpulse Trial Enrollment Completed; Results Due This Year
145 PF patients now participating in REBUILD study, Bellerophon said
The Phase 3 REBUILD clinical trial testing INOpulse (inhaled nitric oxide) in people with pulmonary fibrosis (PF) has enrolled its last patient.
Recruitment finished sooner than anticipated, according to INOpulse developer Bellerophon Therapeutics. Top-line results are expected later this year and it’s hoped they will support efforts on behalf og INOpulse’s regulatory approval.
“We are pleased to have completed enrollment in this important study sooner than previously anticipated, which represents a significant milestone for Bellerophon, our INOpulse clinical development program, and the [PF] patient community,” Naseem Amin, MD, chairman of Bellerophon’s board of directors, said in a press release. “Based on the earlier than expected enrollment completion, we now expect to report top-line results from REBUILD in mid-2023.”
In PF, scar tissue can build up in the lungs and put pressure on their blood vessels, leading to pulmonary hypertension. INOpulse is a portable system to administer inhaled nitric oxide, a potent vasodilator naturally found in the body that can widen blood vessels and lower blood pressure, thereby reducing pulmonary hypertension.
The Phase 3 REBUILD trial (NCT03267108) is testing the safety and effectiveness of INOpulse in PF patients at risk of developing pulmonary hypertension. Trial enrollment began in late 2020 and late last year Bellerophon was cleared to reduce the number of patients in the study. A total of 145 people are now enrolled, according to the company.
Participants will be randomly assigned to receive nitric oxide treatment or a placebo administered with the INOpulse device through a nasal cannula. The study’s main goal is to assess the effect of treatment on moderate to vigorous physical activity (MVPA), a measure of how active patients are in their daily life, as measured via a sensor on the wrist.
“This study will provide the randomized dataset to evaluate the change in moderate to vigorous physical activity (MVPA) following treatment with INOpulse in patients with [PF],” said Peter Fernandes, Bellerophon’s CEO. “The ability to monitor changes in their level of physical activity, specifically the difference in MVPA as the novel endpoint, which correlates to household tasks and activities of daily living, has the potential to inform directly on the patient’s overall health, well-being, and quality of life.”
Fernandes said the company looks forward to having the top-line results this year and is grateful to the clinical sites for enrolling patients quickly and efficiently.
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