Safety Report Indicates ZYESAMI's Effectiveness Against COVID-19 Respiratory Failure

Pennsylvania-based NRx Pharmaceuticals today announced it had received a first safety report from a hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure.

These patients were treated with ZYESAMI at the first onset of respiratory failure after exhausting remdesivir and other approved therapies.

The safety report indicated that of the first 19 patients treated by Dec. 31, 2021, three had died, and 16 (84%) were reported to be alive by Jan. 22, 2021.

At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home, and two remained in the hospital.

This use of ZYESAMI occurred during the current Omicron variant surge, although these COVID-19 patients were not necessarily tested for the specific virus variant that caused their ICU admission.

These data were included in an application to the U.S. FDA for Emergency Use Authorization to treat patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir (Veklury).

These patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who cannot participate in a clinical trial to access specific unapproved treatments.

This data does not involve a control group and are not part of a research study designed to test efficacy.

However, ZYESAMI continues to be tested in the ongoing NIH-sponsored ACTIV-3b (TESICO) clinical trial that has now accrued two-thirds of its targeted enrollment.

Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970.

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 NRx.

NRx Pharmaceuticals is located in Radnor, PA, and draws upon more than 300 years of collective, scientific, and drug-development experience to improve patients' health.