NeuroRx, Relief Therapeutics and the Quantum Leap Healthcare Collaborative have signed a clinical trial participation agreement to include Zyesami (RLF-100: aviptadil) in the I-SPY COVID-19 Clinical Trial.
A Vasoactive Intestinal Polypeptide (VIP) formulation, Zyesami will be studied as one of the first drugs for respiratory failure in critically ill Covid-19 patients.
Earlier, the US Food and Drug Administration (FDA) granted ‘Fast Track’ designation to Zyesami for treating critical Covid-19 in patients with respiratory failure.
The inclusion comes after a request from the US Department of Health and Human Services and the Department of Defense.
Sponsored by Quantum Leap, the platform trial is evaluating multiple drugs for treating patients hospitalised or in intensive care units with critical Covid-19.
It is designed to quickly detect those agents that can lower disease severity, as well as cut down mortality rate, lowering or avoiding time on ventilation and other longer-term comorbidities.
In the trial, participants will be given one of the investigational agents being studied and the results will be compared to the current standard of care.
NeuroRx CEO and chairman Jonathan Javitt said: “We at NeuroRx, together with our partners at Relief, are honoured to have been selected by Quantum Leap for inclusion in the I-SPY trials platform.
“This will enable us to gather data on the use of inhaled aviptadil in the treatment of critical Covid-19, as a complement to data on the use of intravenous aviptadil in the Phase IIb/III trial we are just concluding.”
Currently, the drug is being analysed in two placebo-controlled US Phase IIb/III trials in Covid-19 related respiratory deficiency.
Last November, NeuroRx, Relief announced initial successful results from expanded access use of RLF-100 in patients suffering with critical Covid-19 and severe comorbidities, with 72% of them admitted into ICU surviving.