schreef:
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.
(PRNewsfoto/Quantum Leap Healthcare Collabo)
(PRNewsfoto/Quantum Leap Healthcare Collabo)
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
ZYESAMI™ (Aviptadil Acetate) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) that was first discovered by the late Prof. Sami Said. ZYESAMI™ (Aviptadil) is named in his honor, and was selected for participation in the I-SPY COVID Trial study, in part, because of its anti-inflammatory properties. NRx Pharmaceuticals recently submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration for ZYESAMI™ to treat Critical COIVD-19 patients with respiratory failure.
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.