Date: 29-Jun-2020

US FDA Grants Fast Track Status To Aviptadil To Treat Respiratory Distress In COVID-19

NeuroRx, in partnership with Relief Therapeutics announced that the US 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.

Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the Alveolar Type II cell that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.

COVID-19-related death is primarily caused by Respiratory Failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Corona Viruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. 2 These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.

Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression. (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.