By Dhirendra Tripathi
Investing.com – NRX Pharmaceuticals stock (NASDAQ:NRXP) surged 11.5% in Wednesday’s premarket trading after the company said it had placed a fresh request to the FDA to give the ‘breakthrough therapy’ label to its drug that’s meant to help patients severely ill with Covid-19 and respiratory failure who have been already treated with Gilead Sciences' (NASDAQ:GILD)’ remdesivir.
Patients who received NRx’s zyesami (aviptadil) after remdesivir had three-fold increased odds of being alive and free of respiratory failure after both 28 days and 60 days, compared with those that received a placebo, the company said.
Patients at the highest risk -- those on ventilators -- demonstrated a ten-fold higher odds of survival, the company said.
Aviptadil is a synthetic form of vasoactive intestinal polypeptide (VIP) first discovered by the late Professor Sami and owes its branded name, ‘Zyesami’, to him. Although primarily concentrated in the lung, it was first purified from the intestinal tract.
VIP binds specifically to the alveolar type II cell in the air sac of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity. 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, hallmarks of Covid-19.
NRx claims that other than zyesami, no currently proposed treatments for Covid-19 specifically target this mechanism of action.
The fresh request by the company comes after the FDA rejected its previous request for emergency use authorization and breakthrough therapy designation for zyesami. The regulator asked the company to file a new plea based on new clinical evidence that aviptadil may demonstrate a significant improvement in treatment over existing therapies.