Posted on 03/29/2021 9:19:32 AM PDT by rxsid
NeuroRx Announces ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19
RADNOR, Pa., March 29, 2021 /PRNewswire/ -- NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007).
To the company's knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration ("FDA") for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).
Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs.
NeuroRx has announced the commencement of a clinical trial of inhaled ZYESAMI™ for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure. NeuroRx has also announced the inclusion of inhaled ZYESAMI™ in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure. The company has signed a clinical trial participation agreement with the National Institutes of Health.
The study's coordinating committee, including Professors Dushyantha Jayaweera, MD, FACP (University of Miami), Richard Lee, MD, (UC Irvine), and J. Georges Youssef, MD (Houston Methodist Hospital) commented, "The 60-day observation framework implemented last month by FDA for critically ill patients with COVID-19 is more consistent with the clinical course of this lethal disease than the 28-day time frame originally adapted from other conditions that cause respiratory distress. The association of baseline oxygenation status (high flow nasal oxygen vs. ventilation) is not surprising in that patients who require mechanical or noninvasive ventilation in order to maintain blood oxygen are likely to have substantially more damage to the lining of their lungs compared to patients whose blood oxygen level can be maintained with high-flow oxygen delivered to the nose. The finding that patients fared substantially better in tertiary care centers as compared to regional hospitals may be influenced by the intensity of the public health crisis at the regional hospitals that participated in the study, all of which were operating at 200% or higher overcapacity in their intensive care units with implementation of temporary ICU beds and shortages of critical care staff."
Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, "ZYESAMI has now demonstrated itself in a phase 2/3 trial, conducted under FDA Fast Track Designation, not only to shorten hospitalization (as was previously reported) but also to save lives and increase the likelihood of patients returning safely home to their families. In exactly 12 months, a lifesaving drug has advanced from concept to clinical success in partnership with Relief Therapeutics in the midst of a public health emergency that has claimed the lives of millions. Today's findings confirm the often dramatic clinical success that has been seen in numerous patients treated in the US and abroad under emergency use protocols. We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible."
An investor conference call will be held today, March 29th at 8:30am EDT. Participants can dial (+1) 866-373-3402 or join via webcast at https://78449.themediaframe.com/dataconf/productusers/nrx/mediaframe/44307/indexl.html. <-- Link to the press release by Dr. Javitt
FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients (Aviptadil) (08.06.2020)
New Drug Promises “Rapid Recovery From Respiratory Failure” (Covid-19 Therapeutic) (10.15.2020)
NeuroRx Announces ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19
Sounds like Good News!
What’s the point of a life saving therapeutic when I need to get a vaccine pass from the government to go food shopping ?
Poshridexifil with Metraczklomine!
Having therapeutic options is a big deal.
It sure is. Add Hydroxychloroquine, Ivermectin, nebulized budesonide, oral prednisone, methylprednisolone, dexamethasone, and colchicine to the mix. They are likely much cheaper and readily available too.
Who needs the Franken-shot and a "vaccine passport" to buy and sell, anyhow?
Hey hey,
The government is only trying to help you.
sarc-
Everything you need to know about the COVID-19 therapy trials
https://pharmaceutical-journal.com/article/feature/everything-you-need-to-know-about-the-covid-19-therapy-trials#Aviptadil
Keep an eye out for Zyesami. It's very significant efficacy, safety and presumed relative low cost puts it in position to become a wider known/used therapeutic in the months/years to come.
Good link. Thanks.
Right. You can take ZYESAMI. Or you can take Hydroxy and zinc. Or Ivermectin and zinc. Or Quercetin and zinc.
Or Sudafed and vitamin C, for that matter.
I feel like we are lab rats in a giant mind-control experiment.
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