EQS-News

NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100(TM) (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19 - Seite 3

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. Coronaviruses are shown to replicate in alveolar type 2 cells but not in the more numerous type 1 cells. 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(TM), no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

About RLF-100(TM)
RLF-100(TM) (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said's original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100(TM) for the treatment of COVID-19 and awarded Fast Track designation. RLF-100(TM) is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100(TM) under FDA-approved protocols. Information on the RLF-100(TM) Expanded Access program can be found here: https://www.neurorxpharma.com/our-services/rlf-100.