NRx Asks Breakthrough Tag for Therapy for Patients at Risk of Death from COVID

 - Breakthrough Therapy Designation request focused on patients whose respiratory failure has progressed despite treatment with Remdesivir

- Filing is based on FDA request for clinical data on the effectiveness of ZYESAMI compared to Remdesivir and other approved therapies

- Patients treated with ZYESAMI vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60

- A highly significant (P=.006) four-fold increased odds of survival is seen in these patients

- Patients at the highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival (P=.03)

- US National Institutes of Health-sponsored trial comparing ZYESAMI and Remdesivir individually and in combination continues to demonstrate safety and has enrolled more than 350 patients

https://finance.yahoo.com/news/nrx-pharmaceuticals-files-breakthrough-therapy-114800045.html