Benzinga | Nov 2, 2021 11:15AM EDT

NRx Pharma Highlights New Safety Report For ZYESAMI In National Institutes Of Health-Sponsored ACTIV-3b Critical Care Study In Patients With Life-Threatening COVID-19

- After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients

- ACTIV-3b Critical Care Study is Evaluating ZYESAMI(r) (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo

- ACTIV-3b Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19

RADNOR, Pa., Nov. 2, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage, biopharmaceutical company, today provided a new safety update on ZYESAMI(r) (aviptadil), which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its third scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of more than 300 patients and recommended continued enrollment.





"This safety analysis by the NIH continues to contribute evidence that ZYESAMI is safe to administer to patients with Critical COVID-19, who have no other therapeutic alternative," said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx.

"This safety analysis by the NIH continues to contribute evidence that ZYESAMI is safe to administer to patients with Critical COVID-19, who have no other therapeutic alternative," said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "We now have safety data on nearly 600 patients treated with ZYESAMI in the ICU or step-down unit, with no reports of unexpected, drug-related, serious adverse events."

ACTIV-3b is a randomized, placebo-controlled clinical trial testing ZYESAMI and remdesivir (Veklury) -- alone and in combination -- in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.

On May 31, 2021, NRx submitted a request for Emergency Use Authorization to the US Food and Drug Administration (FDA) for ZYESAMI for the treatment of patients suffering from Critical Covid-19 with respiratory failure. That request remains pending.

ACTIV-3b represents one of three ongoing studies of ZYESAMI in Severe or Critical COVID-19.