INOpulse System as PH Treatment Moves into ‘Speedier’ Phase 3 Clinical Trial

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by Magdalena Kegel |

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PH therapy in clinical testing

Bellerophon Therapeutics recently offered an update on the company’s INOpulse system, as part of its first quarter 2017 financial report. The system is in clinical testing as a therapy for three types of pulmonary hypertension.

The Phase 3 INOpulse program for pulmonary arterial hypertension (PAH) has been modified to speed up its clinical development. Meanwhile, a Phase 2 trial of INOpulse in patients with pulmonary hypertension linked to idiopathic pulmonary fibrosis (PH-IPF) is advancing, with new data to be presented at the upcoming American Thoracic Society (ATS) 2017 International Conference in Washington, D.C.

“Overall progress in our ongoing clinical programs has been encouraging and I am pleased with data recently reported in both PAH and in pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF),” Fabian Tenenbaum, chief executive officer of Bellerophon, said in the financial release.

“There are currently no therapies to treat pulmonary hypertension in IPF and 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,” Tenenbaum said. “In addition, we expect to communicate the results of our Phase 2 trials (NCT01728220) for INOpulse therapy to treat pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) around mid 2017.”

INOpulse is a device that delivers inhaled nitric oxide in a pulsatile manner through a nose cannula. The portable device is as big as a paperback book, and is programmed to automatically adjust dosing to a patient’s breathing pattern. In this way the dose becomes constant over time, according to the company.

Nitric oxide acts to reduce lung blood pressure by enlarging blood vessels, but is rapidly inactivated when it comes into contact with blood. The inhaled drug is intended to have a lower risk of side effects compared to drugs taken systemically.

The U.S. Food and Drug Administration (FDA) recently approved a modification of the Phase 3 program of INOpulse in PAH. The program consists of the INOvation-1 study (NCT02725372) and a second confirmatory randomized withdrawal study.

According to the updated plan, 40 patients from the INOvation trial will be recruited to the randomized withdrawal study. In this way, the company will not have to recruit additional patients and will not have to run another Phase 3 trial. Instead of the previous plan of recruiting 470 patients, only 188 will now be needed to gather data on the system’s efficiency and safety. The INOvation-1 study is currently enrolling patients at sites across the U.S. and elsewhere; more information is available on its clinical webpage.

The FDA judged that the two studies can provide sufficient information to support a New Drug Application (NDA) for INOpulse — significantly speeding up the estimated time of development and potential approval.

Phase 2 trial data presented at an earlier scientific meeting indicated that the INOpulse treatment lowered lung blood pressure in patients. Phase 3 results are not expected until the end of this year (interim results), with final results coming in 2018.

“We were encouraged with the results of the recent investigator-initiated study of patients with PAH, which suggested that pulsed inhaled nitric oxide, as delivered by our INOpulse device, may have an important role in blunting pulmonary pressures both with and without exercise in PAH,” Tenenbaum said.

“Bellerophon’s progress toward our clinical and regulatory goals is positive news for the many patients who continue to suffer from poor outcomes with currently available treatments for PAH or with unmet medical needs in PH-IPF and PH-COPD,” he concluded.

A Conversation With Rare Disease Advocates