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FDA approves expanded access to Wilmington company’s experimental Covid-19 therapy

By John George, Senior Reporter – Philadelphia Business Journal

The Food and Drug Administration on Wednesday granted NeuroRx and partner Relief Therapeutics an expanded access protocol for their experimental treatment of respiratory failure in Covid-19 patients.

The action means Covid-19 patients who are not eligible to enroll in the ongoing phase-II/III clinical trials for the therapy because of other medical conditions can still get access to the treatment. The protocol specifically makes the treatment available to pregnant women.

“By granting this expanded access protocol, the FDA has made a potentially life-saving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, NeuroRx’s CEO.

NeuroRx is based in Wilmington and has its clinical operations in Radnor.

Although the new drug candidate, RLF-100, is still in the testing stage, NeuroRx and Relief Therapeutics said a rapid recovery from respiratory failure in Covid-19 has been seen in patients treated under the FDA’s emergency use authorization.

RLF-100 is a patented formulation of Aviptadil, a synthetic human vasoactive intestinal polypeptide. Human vasoactive intestinal polypeptide, discovered in 1970, is produced throughout the body and is primarily concentrated in the lungs.

Javitt, in June, said SARS-CoV-2 — the virus that causes Covid-19 — likely attacks the body by entering the body’s small population of what are known as alveolar type II cells in the lung. “[It’s] almost like targeting the needle in the haystack,” he said. “Without type II cells, the lung cannot transmit oxygen — which is exactly what happens in Covid-19.”

RLF-100 is designed to inhibit pro-inflammatory cytokines and protect alveolar type 2 cells in the lungs.

NeuroRx, founded in 2015, is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca.

Relief Therapeutics Holdings of Geneva, Switzerland, owns a group of companies focused primarily on clinical-stage projects based on molecules of natural origin, such as peptides and proteins, with a history of clinical testing and use in human patients.