FDA granted Bellerophon emergency expanded access for INOpulse for treatment of COVID-19 virus

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On Mar. 20, 2020, Bellerophon Therapeutics announced the U.S. Food and Drug Administration (FDA) had granted emergency expanded access allowing its proprietary inhaled nitric oxide (iNO) delivery system, INOpulse’, to immediately be used for the treatment of COVID-19.

NO is a naturally produced molecule that is critical to the immune response against pathogens and infections. In vitro studies have shown that NO inhibits the replication of severe acute respiratory syndrome-related coronavirus (SARS-CoV) and improves survival for cells infected with SARS-CoV.

Inhaled nitric oxide acts as a vasodilator, relaxing the lungs’ muscles and blood vessels, and is used in hospitals worldwide. Bellerophon has been researching its use to combat potentially harmful high blood pressure in the lungs among patients with chronic obstructive pulmonary disease, pulmonary fibrosis, interstitial lung disease and sarcoidosis.

The compound has also been tested as a potential treatment for the novel coronavirus’ closely related predecessor—the strain behind the SARS outbreak in the early 2000s. Previous studies showed that nitric oxide slowed down the replication of that virus and reduced the need for long-term ventilator support.

Prior to the outbreak, Bellerophon had been building up inventory of its INOpulse device for a planned, large phase 3 trial in pulmonary fibrosis—which the company is currently looking to divert to hospitals in need, CEO Fabian Tenenbaum told FierceMedTech in an interview.

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Source: Fierce Biotech
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