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Re: changes_iv post# 42695

Friday, 10/08/2021 6:31:22 AM

Friday, October 08, 2021 6:31:22 AM

Post# of 44690
DOES REMDESIVIR NEED A GOOD REPLACEMENT AS SOC???

Zyesami (Aviptadil) COVID-19 Therapeutic

Description

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020.

VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.

Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the company.

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, says the company.
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"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm the mechanism of action," stated Prof Jonathan Javitt, M.D., MPH, Chairman and CEO of NRx, on August 30, 2021. "This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the U.S. FDA."

https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic