GRANT EMERGENCY USE AUTHORIZATION TO ZYESAMI for COVID-19
GRANT EMERGENCY USE AUTHORIZATION TO ZYESAMI for COVID-19
Help Us Save Lives TODAY
SIGN THE PETITION
Recently published study data from two clinical studies show that critically-ill patients in the ICU for COVID-19 who got ZYESAMI were 4x more likely to survive, compared to those who got placebo! These patients have no other treatment and deserve a chance at life. ZYESAMI has been shown to be safe and nontoxic in many thousands of people around the world.
Sign the petition to urge the FDA to immediately authorize Aviptadil for emergency use.
There is clear and undeniable evidence that the drug ZYESAMI, also known as RLF-100 and Aviptadil successfully treats severe COVID-19. There is growing public outcry for this therapeutic drug to be made more accessible to severe COVID-19 cases. Thousands of people each day are dying while the red tape of bureaucracy prevents this from being used. With a great safety profile, antiviral properties and lung protective and restorative properties it is not only inhumane, unethical and cruel for this drug to be held up from being used.
We request that the US FDA immediately grant EMERGENCY USE AUTHORIZATION to ZYESAMI.
Clinical trials have reported prompt recovery (within days) of respiratory failure patients with Aviptadil medications, and US FDA has approved its use in humans under the investigational new drug category. 196 patients were treated during clinical trial phase-2b/3 of FDA (www.clinicaltrials.gov NCT 04311697).
The study was performed at 12 different medical centers in the USA.
Not only did ZYESAMI increase survival from COVID Respiratory Failure compared to placebo in these 196 patients, it was shown to block the cytokine storm and to increase blood oxygenation within a day compared to placebo. The same results were found in a trial of 21 highly comorbid patients treated at Houston Methodist Hospital, compared to those treated with the standard of care. (http://dx.doi.org/10.2139/ssrn.3665228
Currently, 25 U.S. hospitals have enrolled patients in the EAP, nearly all of which are community hospitals, suggesting that aviptadil can demonstrate effectiveness in the hands of front-line physicians who deliver the majority of care to patients with Critical COVID-19. Physicians enrolling patients in the EAP have routinely reported that initial patients at their sites have frequently been in the ICU for several weeks without recovery prior to treatment with aviptadil. As patients are treated earlier in the course of their ICU stay, there is an emerging clinical impression that aviptadil has an even greater impact on recovery.
"We are reassured that emerging real-world data on the use of aviptadil in improving survival in patients with Critical COVID-19 are comparable to results seen in the hands of major academic teaching centers. We hope that these findings are viewed as encouraging at a time when many Americans, including the doctors, nurses, and other front-line caregivers who are the heart of our initiative, are celebrating the Thanksgiving holiday at a distance from their loved ones." said Prof. Jonathan C. Javitt, MD, MPH, CEO and founder of NeuroRx, Inc.
ABOUT VIP IN LUNG INJURY
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Saidin 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than aviptadil, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
ZYESAMI (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said'soriginal work for which FDA awarded an Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of aviptadil for the treatment of COVID-19 and awarded Fast Track designation. aviptadil is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with aviptadil under FDA-approved protocols. Information on the ZYESAMI Expanded Access program is at NRx Right To Try