ZYESAMI™ (AVIPTADIL®) ZYESAMI™ (Aviptadil acetate), a synthetic form of human Vasoactive Intestinal Peptide (VIP), is a substance produced by the body, that amongst other functions, helps protect cells against inflammatory conditions. VIP has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients suffering from Critical COVID-19 with respiratory failure, and is now in clinical trials. The FDA has also provided an Expanded Access Protocol for ZYESAMI™, a destination that an investigational medicine is intended to treat serious or life-threatening diseases or conditions, and has shown potential to address unmet medical needs. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells in the lung, the same cells that bind the SARS-CoV-2 virus. VIP is believed to protect those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cytopathy (cell death), and upregulating the production of surfactant, the loss of which is increasingly implicated in COVID-19 respiratory failure. Ongoing trials show VIP may also inhibit the replication of the SARS-CoV2 virus. In the most recent Phase 3 trial for ZYESAMI™, data showed ZYESAMI™ was more effective than placebo in treating patients suffering from Critical COVID-19 with respiratory failure, reducing their hospital stay, and increasing their likelihood of survival. The most common adverse event noted in the data was diarrhea.
ZYESAMI™ Clinical Development Program
Sponsored by NRx. Enrolled 196 Critical COVID-19 patients who were randomized in a placebo-controlled trial with identical drug and placebo infusion bags.
In this study, patients who were hospitalized for Critical COVID-19 infection with respiratory failure were randomly assigned to ZYESAMI™ (Aviptadil) administered by intravenous infusion in addition to maximal intensive care vs. maximal intensive care alone. Primary endpoints were improvement in blood oxygenation and mortality.
Sponsored by NRx. This trial enrolls patients who have severe COVID-19, but have not yet developed respiratory failure. Patients are randomly assigned to either ZYESAMI™ or placebo in order to determine whether treatment with ZYESAMI™ is associated with a reduced likelihood of progressing to Critical COVID-19, improved survival, and a shortened hospital stay.
AVICOVID-2 is in Phase 2/3
Sponsored by the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services. This trial enrolls patients with Critical COVID-19 who have already developed respiratory failure and seeks to determine whether treatment with inhaled ZYESAMI™ is associated with an increased likelihood of being alive and free from respiratory failure at 90 days compared to treatment with placebo or other drugs.
Sponsored by the National Institutes of Health. This trial enrolls patients with Critical COVID-19 who have already developed respiratory failure and seeks to determine whether treatment with intravenous ZYESAMI™ is associated with an increased likelihood of being alive and free from respiratory failure at 90 days compared to treatment with placebo or r Remdesivir) alone or in combination with Zyesami.