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NeuroRx reports Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ (aviptadil) in Reducing Hospital Stay among Patients with Respiratory Failure due to Critical COVID-19
If Authorized for Use, ZYESAMI™ Would be First Treatment Specifically for Critically Ill Patients with Respiratory Failure RADNOR, Pa., Feb. 9, 2021
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"If Authorized for Use, ZYESAMI™ Would be First Treatment Specifically for Critically Ill Patients with Respiratory Failure\n\n\nRADNOR, Pa., Feb. 9, 2021 /PRNewswire/ -- NeuroRx, Inc. today reported preliminary results from their Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) performed in collaboration with Relief Therapeutics Holdings, AG (SIX:RLF; OTCQB:RLFTF) in patients with respiratory failure due to Critical COVID-19. The study showed that patients who were treated with the maximal standard of care plus ZYESAMI were discharged sooner from the hospital compared to those treated with placebo plus maximal standard of care (SOC). If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure. \n\n \n \n \n \n \n \n\n \nJonathan Javitt, M.D., M.P.H., CEO of NeuroRx, said: \"We are greatly encouraged by these preliminary findings and believe they are indicative of a biologic effect of aviptadil in hastening recovery from Critical COVID-19. We expect to discuss with the Food and Drug Administration and other regulatory authorities the submission of an Emergency Use Authorization (EUA) so that ZYESAMI can be available for treating this population that is at immediate risk of death and for which there is no approved therapy.\" \nWith the improvement in survival since the start of the pandemic, differences in patient survival were not seen at day 28, and patients are now being followed through day 60. The study has not identified an overall difference in the stated primary endpoint of recovery from respiratory failure from summary data. However, investigators are in the process of confirming the timing of each case of recovery from medical records, following which the study's investigators' committee will review each case prior to patient-level unblinding of this endpoint. Those data are expected within a few weeks and will provide further insight into the benefits of ZYESAMI. A blinded substudy of radiographic improvement is similarly underway.\nAmong the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula (HFNC) therapy and with Mechanical Ventilation, ZYESAMI showed an advantage in 15 of 16 comparisons and demonstrated a 40% or better advantage (hazard ratio","length":2965,"tagName":"div"}]