NRx Pharmaceuticals has reported positive safety data from the National Institutes of Health (NIH)-sponsored Phase III ACTIV-3 Critical Care clinical trial of Zyesami (aviptadil) in Covid-19 patients.
An experimental drug, Zyesami is a synthetic form of a vasoactive intestinal polypeptide (VIP), which selectively attaches to the alveolar type II cell (ATII) in the lung’s air sac (alveolus).
VIP is created naturally in the body and can potentially offer lung-protective, anti-viral and anti-inflammatory effects.
The randomised, blinded, placebo-controlled trial is analysing Zyesami as monotherapy or along with antiviral drug, remdesivir, in hospitalised Covid-19 patients with acute respiratory failure.
These subjects needed high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.
Study investigators categorised the trial subjects to receive one of the four therapy regimens of both Zyesami and remdesivir or Zyesami and placebo or remdesivir and placebo or just placebo, apart from the standard of care.
Zyesami is given as a daily 12-hour intravenous dose for three days.
The Data Safety Monitoring Board (DSMB) reported no new safety concerns in ACTIV-3 reviewed data from nearly 140 subjects and advised continuing the subject enrolment.
ACTIV-3 is one among the three trials of Zyesami progressing in severe or critical Covid-19 patients.
Zyesami received fast track designation from the US Food and Drug Administration (FDA) for use in Covid-19 patients.
Earlier this month, NRx Pharmaceuticals entered an agreement with MannKind to create a dry powder formulation of Zyesami for the treatment of various respiratory ailments.
The company reported in July that Zyesami statistically significantly prevented a steep surge in cytokines or cytokine storm in Covid-19 patients in a Phase IIb/III trial.
The trial’s prespecified goal was to analyse the change in cytokine level, as cytokines are linked to mortality in Covid-19 patients.
Apart from Zyesami, NRx Pharmaceuticals is developing an experimental drug, NRX-101, for the treatment of suicidal bipolar depression.
NRX-101 is presently being analysed in Phase III trials with data readouts anticipated next year.