Shares of both NRx Pharmaceuticals (NRXP) and Relief Therapeutics (RLFTF) surged when presented data on Zyesami shows evidence that it prevents cytokine storm in COVID-19 patients.
NRx Pharmaceuticals is slated to present data at the Disease Control and Prevention Summit on July 21, 2021 at 10:10 EST.
The presentation identifies a statistically significant effect of ZYESAMI™ (aviptadil) in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. In the recently-completed phase 2b/3 trial, patients treated with placebo experienced a statistically significant elevation in interleukin 6 (IL-6) cytokine levels, whereas those treated with ZYESAMI™ had a minimal increase in IL-6. Change in cytokine level was a prespecified endpoint of the study.
Health regulators continue to prioritize therapies for COVID-19 which help block the impact of IL-6 cytokines in patients with COVID-19. The anti-cytokine effect of ZYESAMI™ was additionally associated with a significant decrease in 60-day mortality.
NRx has submitted these findings to the US Food and Drug Administration (FDA) as a supplement to its pending application for Emergency Use Authorization, (EUA) and is submitting a biomarker letter of intent to the FDA as part of its biomarker program, authorized under the 21st Century Cures Act.
NRx continues to respond to FDA information requests for additional data in support of the currently pending EUA application for ZYESAMI™ in treating critically-ill patients with COVID-19.