The Warren, New Jersey-based company said the FDA has granted emergency expanded access for its proprietary inhaled nitric oxide delivery system, INOpulse, which would allow it to be immediately used for the treatment of COVID-19.
Nitric oxide is a naturally produced molecule that is critical to the immune response against pathogens and infections.
Lab studies have shown nitric oxide impedes replication of SARS-CoV, a strain of coronavirus that caused the SARS epidemic in 2003, according to Bellerophon. It also improved survival of cells infected by the virus.
SARS-CoV patients treated with INOpulse in clinical studies showed improvements in arterial oxygenation, a reduction in the need for ventilation support and an improvement in lung infiltrates observed on chest radiography, Bellerophon said.