NEURORX

NeuroRx and Georgian Ministry of Health Agree to Initiate Expanded Access Program of ZYESAMI (aviptadil acetate) for COVID-19 Respiratory Failure in Georgia

Retrieved on: 
Wednesday, April 28, 2021
Government procurement in the United States, United States administrative law, Forward-looking statement

We are pleased to initiate an Expanded Access Program of ZYESAMI in Georgia under our oversight with the participation of Denk Pharma Georgia and the Lugar Center for Public Health Research.

Key Points: 
  • We are pleased to initiate an Expanded Access Program of ZYESAMI in Georgia under our oversight with the participation of Denk Pharma Georgia and the Lugar Center for Public Health Research.
  • "\nNeuroRx has signed an agreement to merge with Big Rock Partners Acquisition Corp (Nasdaq:BRPA).
  • Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties.
  • You may obtain a free copy of these documents as described in the preceding paragraph.\n'

Dr. Anthony Fauci Confirms ZYESAMI Phase 3 Trial with Remdesivir at Press Briefing by White House COVID-19 Response Team

Retrieved on: 
Monday, April 26, 2021
Federal government of the United States, Anthony Fauci, White House Coronavirus Task Force, Presidency of the United States, Scientists

The trial, designated as ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)( www.clinicaltrials.gov NCT04843761), will study ZYESAMI to treat severely ill COVID-19 patients.

Key Points: 
  • The trial, designated as ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)( www.clinicaltrials.gov NCT04843761), will study ZYESAMI to treat severely ill COVID-19 patients.
  • Anthony Fauci elaborated on the need for new COVID-19 therapeutics and discussed this trial in a White House press briefing on April 23, 2021.
  • He offered the following comment on the inclusion of ZYESAMI amongst promising COVID-19 therapies, "There\'s a clinical trial of therapeutics for severely ill individuals.
  • Please refer to the White House press briefing here .

NeuroRx Responds to Issues Raised by Relief Therapeutics Regarding ZYESAMI development

Retrieved on: 
Monday, April 19, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments, Food and Drug Administration

NeuroRx has repeatedly advised Relief that it will share all clinical trial data with European and other international regulators as soon as those data are released to the US FDA.

Key Points: 
  • NeuroRx has repeatedly advised Relief that it will share all clinical trial data with European and other international regulators as soon as those data are released to the US FDA.
  • However, NeuroRx has declined to provide unreleased clinical trial data to Relief in a manner that could compromise study integrity.
  • The first scientific report of 60-day data from the phase 2b/3trial is expected to be released imminently.
  • Such forward-looking statements do not constitute guarantees of future performance and are subject to a variety of risks and uncertainties.

NeuroRx Announces Zyesami™ (Aviptadil) Has Been Selected for Inclusion in NIH-Sponsored Global Clinical Trial to Include Aviptadil and Remdesivir

Retrieved on: 
Tuesday, April 6, 2021
Companies, Life sciences, Industry economics), Relief Therapeutics, Aviptadil, AstraZeneca, Pfizer, Novartis

Aviptadil is being developed by NeuroRx as ZYESAMI in collaboration with Relief Therapeutics Holding, AG (SIX: RLF, OTCQB: RLFTF).

Key Points: 
  • Aviptadil is being developed by NeuroRx as ZYESAMI in collaboration with Relief Therapeutics Holding, AG (SIX: RLF, OTCQB: RLFTF).
  • The primary endpoint of the trial will be participant recovery from respiratory failure over 90 days.
  • NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD.
  • This press release relates to a proposed business combination and related transactions (the "Transactions") between NeuroRx and BRPA.

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

Retrieved on: 
Monday, March 29, 2021
Medical research, Health sciences, Medicine, Health, Orphan drugs, COVID-19 vaccine, Draft:PPP001, Medical research, Health sciences, Medicine, Health, Orphan drugs, COVID-19 vaccine, Draft:PPP001

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.

Key Points: 
  • 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.
  • 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.
  • 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.

NeuroRx Announces Completion of Data Analysis in Phase 2b/3 Clinical Trial of ZYESAMI™ for the Treatment of COVID-19 Respiratory Failure

Retrieved on: 
Friday, March 26, 2021
Peptides, Aviptadil, Peptide hormones, Vasoactive intestinal peptide, Vasoactivity, Peptide, Hormones, Branches of biology, Organ systems

RADNOR, Pa., March 26, 2021 /PRNewswire/ --NeuroRx, Inc. announces completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI (aviptadil acetate) for the treatment of critically-ill patients with COVID-19 respiratory failure ( www.clinicaltrials.gov 04311697).

Key Points: 
  • RADNOR, Pa., March 26, 2021 /PRNewswire/ --NeuroRx, Inc. announces completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI (aviptadil acetate) for the treatment of critically-ill patients with COVID-19 respiratory failure ( www.clinicaltrials.gov 04311697).
  • A conference call will be held at 8:30am EDT on Monday, March 29th with attendance from corporate leadership and lead investigators.
  • NeuroRx, Inc. has signed an agreement to merge with Big Rock Partners Acquisition Corp.
  • Details may be viewed at http://irdirect.net/filings/viewer/index/1719406/000119312521019278
    Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970.

NeuroRX and TFF Pharmaceuticals Announce Entering Into Feasibility Collaboration

Retrieved on: 
Tuesday, March 9, 2021
Pharmaceutical industry in China, Pharmaceuticals policy, Pharmacy in China, Science and technology in the People's Republic of China, Aviptadil

RADNOR, Pa. and AUSTIN,Texas, March 9, 2021 /PRNewswire/ --NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ: TFFP)are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement).

Key Points: 
  • RADNOR, Pa. and AUSTIN,Texas, March 9, 2021 /PRNewswire/ --NeuroRx, Inc. and TFF Pharmaceuticals, Inc. (NASDAQ: TFFP)are announcing that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement).
  • Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI (aviptadil, synthetic VIP)materials to TFF in order to perform feasibility formulation work and testing.
  • TFF Pharmaceuticals, Inc.is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform.
  • This press release contains forward-looking statements regardingTFF Pharmaceuticals, Inc., including the benefits of the Company's TFF platform and a potential its dry powder version of NeuroRx's ZYESAMI.

NeuroRx Announces that ZYESAMI™ (Aviptadil) has Successfully Demonstrated 10-Day Accelerated Recovery from Respiratory Failure in Critically Ill Patients with Covid-19 Treated with High Flow Nasal Oxygen at 28-Day Interim Endpoint

Retrieved on: 
Tuesday, February 23, 2021
Intensive care medicine, Placebo

At 28 days, patients treated with ZYESAMI demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08).

Key Points: 
  • At 28 days, patients treated with ZYESAMI demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08).
  • Should the above trends continue through day 60, NeuroRx anticipates filing a request for Emergency Use Authorization in this population of critically ill patients (i.e.
  • those on High Flow Nasal Oxygen) who have exhausted all currently approved treatments.
  • We look forward to working with the sponsor to secure emergency use authorization for ZYESAMI in this population of patients."

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

Retrieved on: 
Tuesday, February 9, 2021
Coronavirus disease, Occupational safety and health, Public health, Zoonoses, Health, Biomedical Advanced Research and Development Authority, Articles, COVID-19 drug repurposing research, Cytokine storm

If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.

Key Points: 
  • If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.
  • The study has not identified an overall difference in the stated primary endpoint of recovery from respiratory failure from summary data.
  • We have launched a phase 2/3 trial to explore ZYESAMI's inhaled use in patients who are not yet in respiratory failure.
  • "Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial.

NeuroRx and Relief Therapeutics Report Initial Phase 2b/3 Study Results Demonstrating Significant Benefit of ZYESAMI™ in Reducing Hospital Stay Among Patients with Respiratory Failure due to Critical COVID-19

Retrieved on: 
Tuesday, February 9, 2021
Health sciences, Health, Medicine, Clinical research, Deception, Placebo, Coronavirus disease, COVID-19 drug repurposing research, Treatment and management of COVID-19

If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.

Key Points: 
  • If authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients who are critically ill with respiratory failure.
  • In the study, patients treated with ZYESAMI were discharged earlier from hospital care than those treated with placebo.
  • The data provide support for ZYESAMI as a drug that may help get patients home to their families sooner.
  • We have launched a phase 2/3 trial to explore its inhaled use in patients who are not yet in respiratory failure.