US-Israeli clinical-stage pharmaceutical company NeuroRx and Swiss drug development company Relief Therapeutics have received authorization from the US Food and Drug Administration (FDA) to begin a mid-stage trial for the use of Aviptadil to treat acute respiratory distress in coronavirus patients, the firms announced on Sunday
NeuroRx said the companies are in the process of recruiting study sites and pharmacies to begin a phase two trial. The FDA issued a “study may proceed” letter 24 hours after their investigational new drug application, NeuroRx said in a statement.
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Founded in 2014, NeuroRx develops novel therapeutics for the treatment of central nervous system disorders. Relief Therapeutics, based in Geneva, previously partnered with US multinational biotech firm Biogen to develop Aviptadil for the treatment of pulmonary hypertension, a condition of increased blood pressure within the arteries of the lungs. Symptoms of pulmonary hypertension include shortness of breath, syncope, tiredness, chest pain, swelling of the legs, and an increased heart rate. Symptoms of COVID-19-infected patients may also include shortness of breath, tiredness and chest pain.
Aviptadil is a patented form of vasoactive intestinal polypeptide that has previously shown promise in treating Acute Respiratory Distress Syndrome (ARDS), in which severe inflammation causes the lungs to fill with fluid, the companies said.
FDA has granted orphan drug status to Relief Therapeutics for the development of Aviptadil in ARDS. Coronavirus death is primarily caused by ARDS.
“Should this trial demonstrate efficacy, we have sufficient drug substance in the freezer to treat more than 1 million people,” NeuroRx CEO Jonathan Javitt told Reuters.