NeuroRx, Relief Announce Fast Track Designation for Respiratory Distress Treatment in COVID-19

NeuroRx, in partnership with Relief Therapeutics, announced the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which reduces inflammation in the lungs and protects the alveolar type II cells that are believed to be an entry route for the SARS-CoV-2 to invade the lungs.

As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.

“We at NeuroRx are enormously appreciative of the FDA’s commitment to accelerating the development of any potential treatment for COVID-19. We hope to live up to the trust that has been placed in us by bringing a potentially life-saving treatment to patients,” said Prof. Jonathan Javitt, MD, MPH, CEO and Chairman of NeuroRx.

“This milestone demonstrates the effectiveness of the FDA CoronaVirus Treatment Acceleration Program and the FDA’s achievement in rising up to address the most severe Public Health Crisis of our lifetime,” said former FDA Chief Counsel, Daniel Troy, a member of the Company’s board of directors.

RLF-100 is being tested in Phase 2/3 clinical trials at major medical centers including the University of Miami, Houston Methodist Hospital, University of California-Irvine, the NYU Langone Medical Center, and the Rambam Healthcare Campus (Haifa, Israel). The multicenter clinical trial enrolls 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.

RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said’s original work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is primarily concentrated in the lung and is known to protect against a variety of lung injuries. VIP was awarded Orphan Drug Designation in 2001 by the U.S. FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. The European Medicines Agency awarded orphan drug designation in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis.