NeuroRx has initiated a Phase II/III clinical trial of its inhaled Zyesami (previously RLF-100: aviptadil) for treating patients with severe Covid-19.
Zyesami is a synthetic form of human Vasoactive Intestinal Peptide (VIP).
The trial is being carried out in collaboration with UCI Health of the University of California, Irvine in the US. It was a key site in the recently concluded study of intravenous Zyesami in patients with critical Covid-19 respiratory failure.
UCI Health Division of Pulmonary Diseases and Critical Care Medicine interim chief and trial’s principal investigator Dr Richard Lee said: “We have seen the devastation of Covid-19 firsthand and recognise 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.”
The latest study’s objective is to analyse whether Zyesami administered at the earlier (severe) stage of Covid-19 can lower the chances of progression to critical Covid-19 with respiratory failure, the major cause of death in Covid-19.
The placebo-controlled study plans to enrol 144 subjects.
On establishing clinical safety, the company intends to include a second outpatient cohort of patients.
It will evaluate whether inhaled Zyesami can be used in the at-home setting in patients with early stages of Covid-19 and other viral infections for preventing disease progression and hospitalisation.
NeuroRx CEO and Chairman Dr Jonathan Javitt said: “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.”
The US Food and Drug Administration (FDA) granted IND authorisation to NeuroRx for intravenous and inhaled delivery of Zyesami for treating Covid-19 and awarded Fast Track designation.
Last month, NeuroRx, Relief Therapeutics and the Quantum Leap Healthcare Collaborative signed a clinical trial participation agreement to include Zyesami in the I-SPY COVID-19 Clinical Trial.