Biopharmaceutical company, NeuroRx, reported positive data from its phase 2/3 trial for its therapy, aviptadil acetate (Zyesami), in patients with severe COVID-19.
NeuroRx recently announced it had met its primary endpoint of successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) for its phase 2/3 trial for its investigational therapy aviptadil acetate (Zyesami). Across all patients and sites, aviptadil showed and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site. The therapy was intravenously-administered.
“Zyesami has now demonstrated itself in a phase 2/3 trial, conducted under FDA Fast Track Designation, not only to shorten hospitalization (as was previously reported) but also to save lives and increase the likelihood of patients returning safely home to their families,” Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said.
Aviptadil is a therapy targeting the lungs for patients in COVID-19 respiratory distress, and was developed by NeuroRx in collaboration with Relief Therapeutics.
Aviptadil contains a vasoactive intestinal polypeptide (VIP), a natural occurring peptide in the body that has been shown to protect the lungs from SARS-CoV-2.
VIP was first discovered by the late Dr. Sami Said in 1970. Although first identified in the lung, it was purified from the intestinal tract. VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation.
VIP binds specifically to the alveolar type II cell (ATII) in the air sac of the lung. VIP stimulates ATII cells to make the surfactant that must coat the lining of the lung in order for the lung to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and air sac collapse.
For its phase 2/3 trial, the prespecified analysis of recovery from respiratory failure was found to be clinically and statistically significant in the 127 patients treated by high flow nasal cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, patients treated with aviptadil had a 71% chance of successful recovery by day 28 vs 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs 55% in the placebo group (P = .036). Eighty-four percent of HFNC patients treated at tertiary medical centers with aviptadil survived to day 60 compared with 60% of those treated with placebo (P = .007).
NeuroRx is also going to performing a clinical trial of inhaled aviptadil for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure, as well as the inclusion of inhaled aviptadil in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure.
In a previous story, Javitt spoke to Contagion about the therapy's mechanism of action, and details about their trials.