NRx Pharmaceuticals and Quantum Leap Announce Treatment of Severely Ill COVID-19 Patients with ZYESAMIÔ (Aviptadil) in the I-SPY COVID Trial
SAN FRANCISCO and RADNOR, Pa., July 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP) and Quantum Leap Healthcare Collaborative™ (Quantum Leap) have begun treating patients with inhaled ZYESAMIÔ (Aviptadil), in the I-SPY COVID Trial (NCT04488081), a phase 2 adaptive platform trial aimed at improving treatment for severely and critically ill COVID-19 patients.
The I-SPY COVID Trial utilizes Quantum Leap's adaptive platform trial design methodology, which focuses on the efficient assessment of multiple investigational agents simultaneously.
The objective of the trial is to screen a variety of promising agents for the treatment of severely and critically ill COVID-19 patients. Specifically, the goal is to identify agents that have a high impact on reducing mortality, as well as the need for and duration of mechanical ventilation.
ZYESAMI™ has demonstrated a statistically-significant increase in the likelihood of patients being alive and free of respiratory failure at 60 days when administered by intravenous infusion in a phase 2b/3 clinical trial in post-hoc analyses. In the I-SPY COVID Trial, inhaled ZYESAMI will be given to critically ill patients in order to determine whether inhaled administration has the potential to achieve similar results.
About ZYESAMI™ in COVID-19
VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.
The ATII cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the ATII cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). ZYESAMI™ is currently the only proposed treatment for COVID-19 specifically targeting this mechanism of action.
The Aviptadil arm in the I-SPY COVID trial features nebulized administration in order to maximize the impact of this drug on the respiratory system and to minimize potential systemic side effects.
As noted by Dr. Laura Esserman, CO- PI of the I-SPY COVID Trial, "Based on demonstrating safety and improved time to recovery with intravenous administration in early stages of SARS-CoV-2, Aviptadil is being tested in the ACTIV trials for COVID. We are excited to partner with NRx to test whether nebulized delivery of Aviptadil, which is more easily and directly delivered to the damaged lungs, improves time to recovery and reduces mortality."
"This trial includes some of the sickest patients suffering from COVID-19, and through this study, we believe we will provide positive outcomes to help them recover more quickly and return home to their families," said Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "Being selected for the I-SPY platform allows NRx the opportunity to work with some of the best physicians and scientists leading clinical trials, and we look forward to providing data to health regulatory authorities, pending the outcome of this trial."
This study is a collaboration between members of Quantum Leap, pharma partners such as NRx and the United States government. This work is supported in part, by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in collaboration with the Medical, Chemical, Biological, Radiological and Nuclear (CBRN) Defense Consortium (MCDC).
About the I-SPY COVID Trial
About Quantum Leap Healthcare Collaborative
About NRx Pharmaceuticals
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SOURCE Quantum Leap Healthcare Collaborative
Company Codes: NASDAQ-NMS:NRXP