Bellerophon plans Phase 2 trial of INOpulse for sarcoidosis-related PH
The portable, inhaled nitric oxide device will be studied for six months
Bellerophon Therapeutics is working toward launching a new Phase 2 trial to test INOpulse, its experimental device for inhaled nitric oxide, in people who develop pulmonary hypertension as a complication of sarcoidosis (PH-Sarc).
The announcement was part of a company’s clinical program update that stated Bellerophon received a green light from the U.S. Food and Drug Administration (FDA) to test INOpulse versus a placebo in people with PH-Sarc in a Phase 2 trial.
The six-month study will be double-blinded, meaning that neither its participants nor the researchers will know which treatment participants are receiving until the study is over.
Sarcoidosis is characaterized by the formation of small clumps of inflammatory cells called granulomas in different organs of the body. When granulomas grow in the lungs, they can cause blood vessels to narrow, making it harder for blood to flow through them.
This can lead to pulmonary hypertension, or higher-than-normal blood pressure in the blood vessels that supply the lungs. Pulmonary hypertension puts extra strain on the heart as it works harder to pump blood through the narrowed blood vessels.
INOpulse is a portable device that delivers pulses of a steady dose of nitric oxide based on each person’s breathing pattern. Nitric oxide, a molecule found naturally in the body, causes muscles around blood vessels to relax.
When inhaled via a nasal cannula, it allows the blood vessels in the lungs to open wider. This helps blood to flow more easily through to the lungs, thereby reducing blood pressure and taking the extra strain off the heart.
Earlier trial data
Bellerophon’s plans build on data from an earlier open-label, proof-of-concept Phase 2 clinical trial (NCT03727451) that evaluated the safety and efficacy of increasing doses of INOpulse in eight people with PH-Sarc who were on long-term oxygen therapy. Doses tested ranged from 30 to 125 micrograms per kilogram of ideal body weight per hour.
Right heart catheterization, an invasive test that is used to measure blood pressure in the heart and the lungs, revealed that INOpulse treatment across all doses resulted in a decrease of the mean pulmonary arterial pressure, or the pressure in the blood vessels that supply the lungs.
All patients also experienced a reduction in mean pulmonary vascular resistance, or how hard the heart has to pump blood through to the lungs. There were no treatment-related side effects with higher doses.
INOpulse also is being evaluated as a potential treatment for people at risk of developing pulmonary hypertension due to pulmonary fibrosis, a lung disease characterized by scarring of lung tissue that makes breathing harder.