NRx Pharmaceuticals announced today that it has filed a new Breakthrough Therapy Designation (BTD) request with the US Food and Drug Administration (FDA) focused on patients with critical Covid-19 and respiratory failure who are at immediate risk of death despite treatment with remdesivir and other approved therapies.

NRx filed the request after the FDA’s request for clinical data on Zyesami vs. remdesivir in these high risk patients. Prof. David Schoenfeld, one of the world’s most widely published statisticians with unique expertise in life-threatening diseases of the lung conducted the new analysis.

With the FDA’s support, we believe we have the chance to help more than 100,000 Americans return to their loved ones who otherwise might not live to see next year’s holidays.

Zyesami (aviptadil) has demonstrated a statistically significant two-fold increased odds of survival compared to placebo across all patients and hospitals studied in a randomized trial of 196 patients.  However, in 70% of patients who were already treated with remdesivir and continued to progress despite all approved therapies, Zyesami has demonstrated a highly significant four-fold increased odds of survival compared to placebo at 60 days (P=.006). Moreover, those treated with Zyesami after remdesivir has failed demonstrate a 3-fold increased odds of being both alive and free of respiratory failure at both 28 and 60 days, compared to placebo (P=.03).

The FDA recently declined Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD) for Zyesami and invited a new request based on new clinical evidence that aviptadil may demonstrate a significant improvement in treatment over existing therapies. Based on the FDA’s input, NRx has narrowed its BTD request to treatment of Covid-19 respiratory failure in patients who progress despite treatment with remdesivir and other approved therapies.

“At a time when America is entering a new Covid-related crisis, we thank the FDA for encouraging us to address the subset of patients who have no other approved treatment”, said Prof Jonathan Javitt, MD, MPH, chairman and CEO of NRx Pharmaceuticals. “More than 2,000 Americans died from Covid-19 on Christmas eve. With the FDA’s support, we believe we have the chance to help more than 100,000 Americans return to their loved ones who otherwise might not live to see next year’s holidays.”

Aviptadil is a synthetic form of vasoactive intestinal polypeptide (VIP) first discovered by the late Prof Sami Said in 1970, and Zyesami is named in his honour. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of Covid-19.

NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients. The company is developing the BriLife Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense.