NeuroRx plans to file for emergency use authorization (EUA) for Zyesami after the drug has successfully demonstrated a 10-day accelerated recovery from respiratory failure patients that have critical COVID-19 and have been treated with high-flow nasal oxygen.
"We look forward to reporting the final 60-day efficacy data shortly,” Dr. Jonathan Javitt, the NeuroRx CEO said in a news release. “We are indebted to the researchers, patients, and families who have helped us demonstrate this meaningful clinical benefit for Zyesami.”
Javitt said the drug was named after the professor who discovered its active ingredient.
“We are honored to name the drug in honor of the late Prof. Sami Said, who discovered its active ingredient, VIP,” Javitt said. “Additional efficacy data on patients who require mechanical ventilation will be obtained from ongoing research supported by BARDA and the National Institutes of Health, in addition to our newly initiated study of inhaled use Zyesami in hospitalized patients who have not yet developed respiratory failure.”
At 28 days, patients who were treated with Zyesami showed a 35 percent higher likelihood to recover from respiratory failure.
NeuroRx also plans to file for EUA if the drug continues to show improvement in patients after Day 60.
The active ingredient in Zyesami is vasoactive Intestinal Polypeptide (VIP). It was discovered by Said in 1970. It was first identified in the intestinal tract and is known to be produced throughout the body. It is concentrated in the lungs.
High-flow nasal oxygen was not envisioned at the start of the clinical trial and has the predominant form of treatment in COVID-19 respiratory failure, the news release stated.
