Bellerophon Updates Pulsed, Inhaled Nitric Oxide Clinical Trials for PH, Related Disorders

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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INOpulse system

Bellerophon Therapeutics has updated clinical trials testing its investigative INOpulse system for several forms of pulmonary hypertension (PH). The update is part of the company’s second-quarter 2017 financial report.

The INOvation-1 trial (NCT02725372) seeks to evaluate the safety, tolerability and effectiveness of pulsed, inhaled nitric oxide (iNO) compared to placebo in patients with pulmonary arterial hypertension (PAH). The Phase 3 trial is currently recruiting participants; to date, 50 patients have already enrolled and have been randomized for either iNo or placebo. The trial, to be conducted at 100 clinical sites in 16 countries, expects to have results next year.

A second Phase 3 trial, called INOvation-RW, is a randomized withdrawal study that will enroll about 40 patients from the INOvation-1 study. INOvation-RW will begin in 2018 and results are expected in 2019.

Bellerophon has received a green light from the U.S. Food and Drug Administration (FDA) to investigate the INOpulse system in PH patients with interstitial lung disease. A Phase 2b study is expected to begin in 2018 and was set up after positive results were reported in the Phase 2a study (NCT01728220). In that trial, patients with difficult-to-treat PH-idiopathic pulmonary fibrosis (IPF) improved their respiratory and exercise capacity after therapy with INOpulse. Bellerophon presented those results at the American Thoracic Society International Conference last May in Washington, D.C.

At the conference, researchers from Bellerophon — based in Warren, New Jersey — also presented the outcome of PH patients with chronic obstructive pulmonary disease (PH-COPD) who enrolled in the company’s Phase 2 study. Preliminary results showed that four weeks of treatment with the INOpulse system resulted in clinically significant improvements, shown by increases in blood vessel volume and reduced pulmonary artery pressure.

“We continue to be encouraged with the progress of our Phase 3 clinical program in PAH, as well as Phase 2 programs in pulmonary hypertension associated with interstitial lung disease and chronic obstructive pulmonary disease,” Bellerophon CEO Fabian Tenenbaum said in a press release.

“We are also encouraged by the results of our Phase 2a PH-IPF study which … showed a statistically significant increase in pulmonary blood vessel volume, correlating with the best ventilated areas of the lung,” Tenenbaum said. “We have since received FDA acceptance of our IND [investigational drug application] and Phase 2b study and look forward to initiating the trial around the end of the year.”

Tenenbaum noted that no therapies currently exist to treat pulmonary hypertension in IPF and other interstitial lung diseases.

“We believe that inhaled nitric oxide delivered by means of the INOpulse delivery system is uniquely positioned to provide targeted delivery without the systemic concerns of other therapies,” he said. “We also presented favorable interim results of our Phase 2 study in PH-COPD, which showed targeted vasodilation and a clinically relevant decrease in the pulmonary pressure. We expect to communicate top-line results of this study in the near future.”