NRX Pharmaceuticals (NRXP) and Relief Therapeutics (RLFTF) develops Zyesami (aviptadil) for COVID-19 patients. The drug has previously demonstrated a statistically significant increase in survival of highly comorbid COVID-19 patients in two 60-day trials. The trial provided a threefold, statistically significant increase in likelihood of survival at one year.
Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days. Those findings are soon to be published in a peer-reviewed journal.
Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.
These one-year findings are consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI. ZYESAMI Remains Under Review by the US Food and Drug Administration for Emergency Use Authorization in Patients Suffering Critical Covid-19 with Respiratory Failure.