TEL AVIV, March 29 (Reuters) – The U.S. Food & Drug Administration has authorised the start of a mid-stage trial by U.S.-Israeli NeuroRx and Relief Therapeutics for the use of Aviptadil to treat Acute Respiratory Distress in coronavirus patients.
The companies said on Sunday they are recruiting study sites and pharmacies to begin a phase 2 trial. The FDA issued a “study may proceed” letter 24 hours after their investigational new drug application.
NeuroRx is a privately held drug development company. Relief, headquartered in Geneva, previously partnered with Biogen to develop Aviptadil for the treatment of pulmonary hypertension.
Aviptadil is a patented form of Vasoactive Intestinal Polypeptide that has previously shown promise in treating Acute Respiratory Distress Syndrome (ARDS), the companies said.
Coronavirus death is primarily caused by ARDS, in which severe inflammation causes the lungs to fill with fluid.
“Should this trial demonstrate efficacy, we have sufficient drug substance in the freezer to treat more than 1 million people,” NeuroRx CEO Jonathan Javitt said. (Reporting by Tova Cohen, Editing by Ari Rabinovitch)