$RLFTF (related) DD by rk: From the S-4:
VIP is shown to have important potential effects in the treatment of other lung diseases including Chronic Obstructive Pulmonary Disease (“COPD”), Sarcoidosis, asthma/allergy, and Chronic Respiratory Inflammation Syndrome. NeuroRx intends to research the use of VIP in these and other conditions in the future.
VIP is also known to be active in the brain and NeuroRx plans to explore its potential use in the treatment of Huntington’s Disease, Multiple Sclerosis, and other CNS diseases if an appropriate mechanism of CNS delivery can be developed.
In the Intravenous Trial, 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. NeuroRx hopes to file for and receive EUA for ZYESAMI in the second quarter of 2021, which EUA will provide NeuroRx with a year in which to complete the CMC, plant inspections, and advisory board requirements associated with traditional drug approvals.
ZYESAMI inclusion in NIH TESICO/ACTIV3b Clinical Trial for CriticalCOVID-19 and Respiratory Failure
ZYESAMI has been selected by the steering committee of the Therapeutics for Severely Ill Inpatients withCOVID-19 (“TESICO”) protocol funded by Operation Warp Speed through the National Heart, Lung, and Blood Institute and the National Institute for Allergy and Infectious Disease of the National Institutes of Health (“NIH”). The protocol is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”) public private consortium.
This clinical trial anticipates enrolling 800 patients in study sites located in US, EU, and UK in a factorial design that will compare ZYESAMIto Remdesivir for the treatment of Critical COVID-19 with respiratory failure. The TESICO trial was approved by the FDA and the Advarra IRB in the first quarter of 2021 and recruited its first patient in April 2021.
ZYESAMI inclusion in I-SPY Clinical Trial for severe and critical COVID-19 with early or impending respiratory
failure
NeuroRx has signed a contract with Quantum Leap Healthcare Corporation for the inclusion of ZYESAMI in the I-SPY clinical trial platform, whereby inhaled ZYESAMI will be included as part of a panel of four drugs being tested as part of the I-SPY COVID-19 Trial, an adaptive platform trial for critically ill patients.
Phase IIb/III Clinical Trial for Inhaled ZYESAMI in EarlyCOVID-19
Although NeuroRx’s initial focus has been on the use of ZYESAMI in patients with Critical COVID-19 and respiratoryfailure (i.e., patients who require ventilation, extracorporeal oxygenation, or high flow nasal oxygen to survive), we havereceived permission from the FDA to test inhaled ZYESAMI in patients with early disease.
We believe that inhaled drug will reach the ATII cells in the lung better than the intravenous drug, provided patients are still able to inhale normally and do not have inflammatory debris clogging the alveoli.
NeuroRx has contracted with COVANCE, Inc. to provide Contract Research Organization support for this clinical trial. This clinical trial commenced in January 2021 and is expected to conclude by September 2021.
Clinical Trials of Aviptadil in other lung conditions
Clinical trials of Aviptadil in preparations not formulated by NeuroRx or Relief have been conducted and reported bymothers and are documented in the Aviptadil Investigational Medicinal Products Dossier (appendix).
We are optimistic that the inhaled form of the drug may show benefit in other lung conditions as well. Phase II studies conducted in the 2008-time frame demonstrated statistically and clinically-significant benefits in the treatment of Sarcoid and Pulmonary Hypertension.
Although initial trials in the treatment of pulmonary fibrosis failed, we intend to further explore treatment of both pulmonary and cystic fibrosis. In addition, we intend to address acute lung injury caused by involuntary smoke inhalation, as well chronic lung injury caused by smoking.
https://www.otcmarkets.com/filing/html?id=148...nM0-d1si3h
VIP is shown to have important potential effects in the treatment of other lung diseases including Chronic Obstructive Pulmonary Disease (“COPD”), Sarcoidosis, asthma/allergy, and Chronic Respiratory Inflammation Syndrome. NeuroRx intends to research the use of VIP in these and other conditions in the future.
VIP is also known to be active in the brain and NeuroRx plans to explore its potential use in the treatment of Huntington’s Disease, Multiple Sclerosis, and other CNS diseases if an appropriate mechanism of CNS delivery can be developed.
In the Intravenous Trial, 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. NeuroRx hopes to file for and receive EUA for ZYESAMI in the second quarter of 2021, which EUA will provide NeuroRx with a year in which to complete the CMC, plant inspections, and advisory board requirements associated with traditional drug approvals.
ZYESAMI inclusion in NIH TESICO/ACTIV3b Clinical Trial for CriticalCOVID-19 and Respiratory Failure
ZYESAMI has been selected by the steering committee of the Therapeutics for Severely Ill Inpatients withCOVID-19 (“TESICO”) protocol funded by Operation Warp Speed through the National Heart, Lung, and Blood Institute and the National Institute for Allergy and Infectious Disease of the National Institutes of Health (“NIH”). The protocol is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”) public private consortium.
This clinical trial anticipates enrolling 800 patients in study sites located in US, EU, and UK in a factorial design that will compare ZYESAMIto Remdesivir for the treatment of Critical COVID-19 with respiratory failure. The TESICO trial was approved by the FDA and the Advarra IRB in the first quarter of 2021 and recruited its first patient in April 2021.
ZYESAMI inclusion in I-SPY Clinical Trial for severe and critical COVID-19 with early or impending respiratory
failure
NeuroRx has signed a contract with Quantum Leap Healthcare Corporation for the inclusion of ZYESAMI in the I-SPY clinical trial platform, whereby inhaled ZYESAMI will be included as part of a panel of four drugs being tested as part of the I-SPY COVID-19 Trial, an adaptive platform trial for critically ill patients.
Phase IIb/III Clinical Trial for Inhaled ZYESAMI in EarlyCOVID-19
Although NeuroRx’s initial focus has been on the use of ZYESAMI in patients with Critical COVID-19 and respiratoryfailure (i.e., patients who require ventilation, extracorporeal oxygenation, or high flow nasal oxygen to survive), we havereceived permission from the FDA to test inhaled ZYESAMI in patients with early disease.
We believe that inhaled drug will reach the ATII cells in the lung better than the intravenous drug, provided patients are still able to inhale normally and do not have inflammatory debris clogging the alveoli.
NeuroRx has contracted with COVANCE, Inc. to provide Contract Research Organization support for this clinical trial. This clinical trial commenced in January 2021 and is expected to conclude by September 2021.
Clinical Trials of Aviptadil in other lung conditions
Clinical trials of Aviptadil in preparations not formulated by NeuroRx or Relief have been conducted and reported bymothers and are documented in the Aviptadil Investigational Medicinal Products Dossier (appendix).
We are optimistic that the inhaled form of the drug may show benefit in other lung conditions as well. Phase II studies conducted in the 2008-time frame demonstrated statistically and clinically-significant benefits in the treatment of Sarcoid and Pulmonary Hypertension.
Although initial trials in the treatment of pulmonary fibrosis failed, we intend to further explore treatment of both pulmonary and cystic fibrosis. In addition, we intend to address acute lung injury caused by involuntary smoke inhalation, as well chronic lung injury caused by smoking.
https://www.otcmarkets.com/filing/html?id=148...nM0-d1si3h
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