NRx Pharmaceuticals has reported top-line results from a study where Zyesami (aviptadil) improved survival outcomes at one year in highly comorbid Covid-19 patients.
A synthetic form of a vasoactive intestinal polypeptide (VIP), Zyesami attaches especially to the alveolar type II cell (AT2) in the lung air sac (alveolus).
The trial carried out between June and September 2020 at a tertiary care hospital involved critical Covid-19 patients whose comorbidity level excluded them from the randomised Phase IIb/III clinical trial of Zyesami.
Subjects in this trial were followed up for one year from initial enrolment, NRx noted.
Findings showed that a statistically significant change in survival, as well as recovery from respiratory failure, was reported at 28 days.
According to the top-line data, subjects receiving Zyesami plus standard of care (SoC) had statistically significant three times benefit or 60% chances of being alive at one year versus those given SoC alone.
Subjects were given Zyesami in the trial based on a special medical team that admitted the patient to the intensive care unit (ICU).
Upon ICU admission, all patients were offered care by the same medical team and in line with the same treatment protocols.
Trial principal investigator Dr J Georges Youssef said: “We are still learning so much about Covid-19, especially in patients already managing chronic medical conditions, and continuing to recover from Covid-19.
“These latest data are encouraging and will help those of us on the frontlines treat the sickest Covid patients, potentially providing new treatment options and strategies.”
These one-year data are in line with the greater odds of 60-day survival observed in the already reported findings from the Phase IIb/III randomised controlled trial of Zyesami.
Last month, NRx reported additional data from the Phase IIb/III trial where Zyesami offered a rise in blood oxygen within a day in critical Covid-19 patients with acute respiratory failure.
The US Food and Drug Administration is currently reviewing Zyesami for emergency use authorization (EUA) in critical Covid-19 patients with respiratory failure.