Bellerophon Therapeutics recently provided an update on the clinical development of INOpulse as a treatment for pulmonary arterial hypertension (PAH), as well as for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and interstitial lung disease (PH-ILD).
INOpulse is an inhaled nitric oxide treatment being developed to reduce blood pressure in the lungs by relaxing blood vessels. It is administered through a tube in the nose with a portable device about the size of a paperback book, which automatically adjusts nitric oxide pulses to the patient’s breathing pattern. Nitric oxide is a known potent vasodilator.
In January, the company announced that more than half the PAH patients it expects to recruit for its Phase 3 INOvation-1 study (NCT02725372) had been enrolled. While the enrollment process continues, the company is anticipating the readout of an interim analysis by an independent data monitoring committee, which will define the next steps of the trial.
“The results of the pre-specified interim analysis for INOvation-1, our Phase 3 study in pulmonary arterial hypertension (PAH), are expected shortly. INOvation-1 utilizes an adaptive design, which allows for stopping the trial early for efficacy, continuing to enroll the study as planned, increasing the targeted enrollment size if the original design was slightly underpowered, or stopping the study for futility,” Fabian Tenenbaum, CEO of Bellerophon, said in a press release.
The committee will evaluate data from 75 patients who have completed 16 weeks of treatment in the placebo-controlled phase of the study. Based on their findings, the committee will provide recommendations on how to proceed — whether the trial should continue or be stopped, or if the number of participants should be increased.
Bellerophon announced in March that it expects to release top-line results of the INOvation-1 trial by the end of the year, as well as from its PH-ILD dedicated program, Tenenbaum said.
Supported by positive results from another trial (NCT02267655) in patients with PH associated with pulmonary fibrosis, the company is currently enrolling patients with PH-ILD for a Phase 2b study (NCT03267108).
The previous study showed that INOpulse could improve blood pressure in the main artery supplying blood to the lungs. The treatment also improved patients’ exercise capacity.
The new Phase 2b trial is expected to enroll about 40 PH-ILD patients, including those with pulmonary fibrosis, who have been on long-term oxygen therapy. Participants will be randomized to receive the inhaled nitric oxide formulation or a placebo. Similar to previous trials, the investigators will determine the treatment’s ability to improve patients’ blood flow and exercise capacity.
INOpulse was also evaluated as a treatment for PH-COPD in a Phase 2 trial (NCT02267655). The study included 10 patients with PH-COPD who received treatment for four weeks.
Results revealed that all patients experienced an average 4.2% increase in blood vessel volume upon treatment with INOpulse, a feature associated with better ventilation. The patients also showed reduced pulmonary arterial pressure and improved exercise capacity.
Supported by these findings, Bellerophon, in conjunction with its steering committee, has concluded the design of a new Phase 2b study in PH-COPD, which was also approved by the U.S. Food and Drug Administration.
“We are pleased to have reached an agreement with the U.S. Food and Drug Administration (FDA) on the design, including the primary endpoint, of our planned Phase 2b study,” Tenenbaum said.
Belleropon expects to enroll about 90 patients in the trial who will be treated with INOpulse or a placebo to assess changes in exercise capacity and other secondary endpoints.
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