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NeuroRx, a US-Israeli pharmaceutical company, and Relief Therapeutics, a Swiss drug development company, announced Sunday they received the go-ahead from the Food and Drug Administration (FDA) for phase two trials of a drug that could take on a deadly condition associated with COVID-19.
The companies revealed that the FDA issued a “study may proceed” letter — which does not amount to a fully-fledged drug approval — for the substance to be tried on COVID-19 patients.
The drug in question, Aviptadil, is a synthetic form of a neuropeptide hormone that works to enable communications between neurons in the human nervous system.
The researchers are hoping that Aviptadil will be able to take on the so-called Acute Respiratory Distress Syndrome (ARDS) — a condition that has killed about 50 percent of COVID-19 fatalities.
“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.
ARDS is a respiratory system failure induced by rapid and severe lung inflammation, with shortness of breath — a symptom widely associated with COVID-19 — among its key signs.
It effectively brings to a halt the oxygen and carbon dioxide exchange in the patient’s lungs, necessitating the use of an artificial lung ventilation machine.