By Dhirendra Tripathi

Investing.com – NRX Pharmaceuticals stock (NASDAQ:) 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:)’ 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.

According to the company, patients with the greatest risk — ventilator-dependent patients — had ten times higher survival rates.

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. While it is concentrated in the lungs and intestinal tract, the first time that it was removed from there was in 2005.

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 induces ATII to produce surfactant, which must be coated the linings of the lungs for oxygen exchange with the blood.  Covid-19’s hallmarks are respiratory failure and collapse due to loss of surfactant.

NRx asserts that, except for zyesami and no other proposed treatment for Covid-19, none of the treatments currently being considered specifically target this mechanism.

After the FDA denied its request for an emergency authorization and breakthrough therapy status for zyesami, the FDA has now requested a new request from the company. According to new clinical evidence, aviptadil might offer a substantial improvement over other therapies.