New Drug Could Prove to Be Life-Saving COVID-19 Treatment

Scientists have been able to synthesize a man-made version of a human peptide which 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.

NeuroRX, Inc. (Wilmington, DE, USA) has developed RLF-100 (Aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), which has been granted Fast Track Designation by the US FDA for the treatment of Critical COVID-19 with Respiratory Failure. VIP was first discovered 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 2 cell, which is critical to the 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. VIP binds uniquely to receptors on alveolar type 2 cells in the lung, the same cells that bind the SARS-CoV-2 virus via their ACE2 receptors. VIP protects those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing apoptosis, and upregulating the production of surfactant, the loss of which is increasingly implicated in COVID-19 respiratory failure. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.

The FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. RLF-100 is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Rapid recovery from Critical COVID-19 with respiratory failure has been seen in multiple patients treated with open label VIP under FDA Emergency Use IND. Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19.

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NeuroRX, Inc.