NeuroRx, Inc. announced completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI™ (aviptadil acetate) for the treatment of critically-ill patients with COVID-19 respiratory failure.

The results for the primary endpoint of recovery from respiratory failure and the secondary endpoint of survival through day 60 are in the process of final review by the investigators of the multicenter clinical trial.

Aviptadil, a synthetic form of human Vasoactive Intestinal Peptide (VIP) has been granted FDA Fast Track Designation for the treatment of Critical COVID-19 with respiratory failure and is now in phase 2/3 clinical trials, with initial determinations of safety and non-futility.

Rapid recovery from Critical COVID-19 with respiratory failure as been seen in multiple patients treated with open label VIP under FDA Emergency Use IND.

VIP binds uniquely to receptors on Alveolar Type II 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.

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