Relief Therapeutics, NeuroRx Expand Clinical Trial of RLF-100

Relief Therapeutics and its U.S. partner, NeuroRx, announced the Phase 2/3 clinical trial evaluating RLF-100 as a treatment for critical COVID-19 with respiratory failure has been expanded to include patients receiving high flow oxygen and noninvasive ventilation (CPAP), in addition to those on ventilators. RLF-100 (Aviptadil) is a patented formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in Acute Respiratory Distress Syndrome and chronic lung diseases.

“With the FDA’s expanded definition of critical COVID-19 to include patients on all forms of ventilation and the recent trend at leading hospitals that avoids mechanical ventilators whenever possible for patients with COVID-19, we recognized the potential benefit of extending this clinical trial to patients on newer forms of treatment for respiratory failure,” said Dr. Jonathan C. Javitt, M.D., MPH, CEO of NeuroRx and the national study chair. “The SARS-CoV-2 likely attacks the body by entering the small population of alveolar type II cells in the lung, almost like targeting the needle in the haystack.1  Without type II cells, the lung cannot transmit oxygen, which is exactly what happens in COVID-19. We know, from 50 years of scientific research, that VIP binds specifically to the type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.2”

The multicenter clinical trial will enroll patients with critical COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality and improve blood oxygenation in this condition by rescuing alveolar type II cells from the SARS-CoV-2 virus.

The trial is being led by NeuroRx, the U.S. development partner of Relief Therapeutics, whose clinical operations are based in Radnor, PA. Patients are being treated under FDA Investigational New Drug clearance, as part of the FDA’s Corona Treatment Acceleration Program (CTAP).