NeuroRx announced initiation of a Phase 2/3 clinical trial investigating the role of inhaled ZYESAMI? (aviptadil) for the treatment of patients with Severe COVID-19 in partnership with UCI Health of the University of California, Irvine. UCI Health was also a site in the recently-completed study of ZYESAMI? for intravenous administration in patients with Critical COVID-19 Respiratory Failure. The objective of the current study is to determine whether aviptadil, administered at the earlier (Severe) stage of COVID-19 can reduce the likelihood of progression to Critical COVID-19 with respiratory failure: the predominant cause of death in COVID.

ZYESAMI? is a synthetic form of human Vasoactive Intestinal Peptide (VIP). Emerging data indicate that the drug protects the alveolar type II cells upon which the lung depends for production of surfactant and which are the primary target of the SARS-CoV-2 Coronavirus. Loss of surfactant causes the alveolar collapse that is the hallmark of radiographic change in COVID-19. VIP blocks replication of the Coronavirus, increases production of pulmonary surfactant, and blocks the virus-induced production of inflammatory cytokines in laboratory experiments.

"We are excited to be the first clinical site for this crucial study, which aims to prevent patients from progressing to respiratory failure and being admitted into the ICU," said Dr. Richard Lee, Interim Chief of UCI Health's Division of Pulmonary Diseases and Critical Care Medicine and the Principal Investigator for the clinical trial. "We have seen the devastation of COVID-19 firsthand and recognize the importance of investigating all potential therapeutics, especially one like ZYESAMI?. Its mechanism holds promise as a treatment for patients in the ICU with Critical COVID-19 and possibly also in the earlier stage of the disease, to reduce disease progression and respiratory failure."

Nearly 90 million Americans currently live in a county where ICU bed occupancy averages 90% or greater, according to data provided by the US Department of Health & Human Services (HHS). In Orange County, CA, where UCI Health is located, 90.0% of ICU beds and 80.7% of hospital beds are currently occupied, underscoring the dire need for a treatment that mitigates COVID-19 progression and, thereby, ICU admissions.

The placebo-controlled study is targeted to enroll 144 patients. Once clinical safety is established, NeuroRx will initiate a second outpatient cohort of patients with the aim to determine whether inhaled ZYESAMI? can be used at home in patients with early stages of COVID-19 and perhaps other viral infections in order to prevent disease progression and hospitalization.

"We are welcome the partnership of UCI Health as our lead clinical site," said Dr. Jonathan Javitt, MD, MPH, CEO and Chairman of NeuroRx. "Their nationally recognized leadership in the treatment of COVID-19 is inspiring. As increasingly virulent strains of the Coronavirus emerge, threatening the efficacy of existing vaccines, we are counting on UCI to continue to help us chart a forward path. Naturally, we look forward to honoring our collaboration agreement with our partner Relief Therapeutics on this important project."