KEY POINTS

  • Aviptadil has been around for two decades and used to treat sarcoidosis, pulmonary fibrosis and bronchospasm
  • The drug will be tested on an estimated 144 patients by University of Miami, Houston Methodist Hospital, the University of California-Irvine, NYU Langone Medical Center and Rambam Healthcare Campus in Haifa, Israel
  • Aviptadil, RLF-100, is a synthetic version of the vasoactive intestinal peptide

A drug that mimics a peptide produced by the bowel has been fast-tracked by the Food and Drug Administration to treat COVID-19 lung inflammation, NeuroRx Inc. announced Wednesday. The drug protects cells believed to act as a gateway for the coronavirus to attack the lungs.

NeuroRx said the drug – RLF-100, sold under the brand-name Aviptadil – will be evaluated in phase 2 and 3 clinical trials at major medical centers at the University of Miami, Houston Methodist Hospital, the University of California-Irvine, NYU Langone Medical Center and Rambam Healthcare Campus in Haifa, Israel. Results indicate the drug decreases mortality and improves blood oxygenation by targeting type 2 alveolar cells, which keep airways open, NeuroRx said in a press release.

Aviptadil is a synthetic version of the vasoactive intestinal peptide, a molecule produced naturally by the body. It is manufactured by NeuroRx and Relief Therapeutics (RLFTF).

Aviptadil has been on the market for 20 years and is used to treat sarcoidosis, pulmonary fibrosis and bronchospasm. The trial involves administering the drug intravenously to patients with acute respiratory distress syndrome caused by COVID-19. Animal models indicated the drug can protect the type 2 aveolar cells from injury, averting respiratory failure. Patients placed on ventilators for respiratory failure have an 80% mortality rate.

The drug also has been tested in Europe with minor adverse effects on blood pressure and the heart.

Trials also are planned for inhaled version.

The clinical trial is expected to involve 144 adults. Pregnant women and people with AIDS, other terminal conditions and those who had suffered strokes in the last year were among those excluded.

The FDA has yet to give final approval to any drug for COVID-19 treatment, but hundreds are under investigation. Among the most promising treatments in clinical trials is a combination of Gilead’s (GILD) remdesivir and the inexpensive steroid dexamethasone, and a combination of remdesivir and ViralClear's merimepodib.