NRx Pharma Says I-SPY Study Of Inhaled Zyesami In Critical COVID-19 Stopped

Quantum Leap Healthcare Collaborative (QLHC) announced that the nebulized form of NRx Pharmaceuticals Inc's NRXP Zyesami (Aviptadil) in the I-SPY COVID Trial of critical patients had been stopped. 

• The I-SPY COVID Trial is a phase 2 trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL. 
• The trial o identify those agents that could potentially reduce the time to recovery by approximately 50% or the risk of mortality in critically ill COVID-19 patients.
• The data suggested a low probability that adding a dose of nebulized Aviptadil to backbone therapy via mouthpiece administration would improve outcomes. 
• At the time of discontinuation, the hazard ratio for recovery favored placebo.
• The findings in the current I-SPY study may be due to the difficulty of effectively delivering nebulized medications via mouthpiece to critically ill patients when they are on high flow oxygen or nebulized into the breathing circuit for mechanically ventilated patients. 
• The intravenous form of Zyesami is currently being tested in the ACTIV-3b Phase 3 trial being conducted by the National Institutes of Health, a separate clinical trial of critically ill patients, which continues enrolling. 
• Related: NRx Pharma's COVID-19 Vaccine Candidate Show Potential Against Omicron Variant.
• According to the Q4 earnings release, NRx is exploring inhaled Zyesami for less severe COVID-19 and other respiratory diseases in the future and also decided to no longer pursue the BriLife COVID-19 vaccine project.
• The Company held cash of $27.6 million. It completed a $25 million private placement financing in February 2022. NRx believes it has sufficient cash to support operations for at least 12 months.
• Price Action: NRXP shares are down 16.8% at $2.37 during the market session on the last check Thursday.