NRx Pharma, Quantum Leap Announce Inhaled ZYESAMIÔ Treatment For COVID-19 Patients

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP) and Quantum Leap Healthcare Collaborative 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.

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.