Aviptadil COVID-19 Therapeutic Description
Aviptadil is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP).
VIP is known to target the VPAC1 receptor of the ATII cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. VIP prevents apoptosis, blocks cytokines, lowers TNFα levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Aviptadil COVID-19 Therapeutic has received orphan drug designation from the US Food and Drug Administration (FDA) in acute respiratory distress syndrome and chronic lung diseases.
The FDA has approved an expanded access protocol for the use of RLF-100 in patients with Critical COVID-19 and Respiratory Failure. RLF-100 remains an investigational drug in clinical trials. The purpose of this expanded access program is to serve patients with a life-threatening need who don’t qualify for or cannot access the FDA phase 2/3 clinical trials currently underway.
Jonathan C. Javitt, M.D., MPH, CEO and Chairman, NeuroRx, Inc., says 'Neither NeuroRx nor the FDA knows at this point whether RLF-100 is safe and effective – just that it has the potential to be safe and effective to treat COVID-19 Respiratory Failure. Because of the life-threatening nature of COVID-19 respiratory failure, our drug – at this point in time – is only being given in the Intensive Care setting, and we can only include physicians who are experts at critical care as investigators under our expanded access protocol.'
NeuroRx, Inc. is developing innovative therapies for high-mortality unmet needs.
Aviptadil COVID-19 Therapeutic Indication
Aviptadil COVID-19 Therapeutic is being used to treat Novel Corona Virus (SARS-CoV-2) known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification.
Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation.
Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation, or mechanical ventilation, will be treated with RLF-100 (Aviptadil).
Aviptadil COVID-19 Therapeutic News
January 18, 2021 - The Government of India's Subject Expert Committee (SEC) meeting examined COVID-19 related proposals under accelerated approval process made in its 140th meeting held on 18.01.2021 & 19.01.2021 at CDSCO, HQ New Delhi.
January 14, 2021 - Like many biopharma companies, the global COVID-19 pandemic has caused delays while also offering opportunities for NeuroRx. The company is based in Radnor, Pennsylvania, and typically is focused on the central nervous system space, developing NRX-100/NRX-101 for suicidal bipolar depression and other neurological disorders.
January 11, 2021- NeuroRx, Relief, and Quantum Leap announce the inclusion of ZYESAMI™ (RLF-100™: aviptadil) in the I-SPY COVID-19 Trial. "We at NeuroRx, together with our partners at Relief, are honored to have been selected by Quantum Leap for inclusion in the I-SPY trials platform. This will enable us to gather data on the use of inhaled aviptadil in the treatment of Critical COVID-19 as a complement to data on the use of intravenous aviptadil in the phase 2b/3 trial we are just concluding. We also hope to demonstrate in a second phase 2b/3 trial that aviptadil can be given in a more convenient mode of administration and show benefit in patients who can self-administer inhaled medications," said Jonathan C. Javitt, MD, MPH, CEO and Chairman of NeuroRx.
December 30, 2020 - FDA rejects COVID-19 emergency approval. “The FDA did not agree to grant (emergency use authorization), as applied for in September,” said Jonathan Javitt, the chief executive officer of U.S.-based NeuroRx, Inc., which has partnered with Relief on aviptadil, an older drug that the companies are seeking to repurpose during the pandemic. The company is now calling the drug Zyesami in its formulation against COVID-19.
November 24, 2020 - NeuroRx and Relief announce initial successful results from expanded access use of RLF-100™ (aviptadil) in patients with Critical COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients. All patients had severe comorbidities (such as organ transplant, recent heart attack, and cancer) that rendered them ineligible for the ongoing randomized, controlled phase 2b/3 trial to ascertain the safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19. Of the 90 patients who have so far reached 28 days of follow-up, 72% survived today 28.
August 3, 2020 - According to the companies, the first report of rapid clinical recovery under emergency use of the drug was from Houston Methodist Hospital doctors.
August 2, 2020 - Critically ill COVID-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said Sunday.
June 9, 2020 - Relief Therapeutics and NeuroRx have expanded the Phase II/III clinical trial of RLF-100 (Aviptadil) to include Covid-19 patients on ventilators, high flow oxygen, and noninvasive ventilation (CPAP).
Aviptadil COVID-19 Therapeutics Clinical Trials
Clinical Trial NCT04536350: Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS
Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, reducing inflammation.
This Phase 1 study will enroll approximately 80 participants and be completed in March 2022.
Clinical Trial NCT04311697: Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)
December 30, 2020, NeuroRx and Relief announced they had concluded Enrollment in their Phase 2b/3 Trial of RLF-100™ for Critical COVID-19 with Respiratory Failure.
Clinical Trial NCT04453839: RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor.
Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization.
Clinical Trial NCT04360096: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19 (AVICOVID-2)
SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite the best available intensive care.
Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression to in severity of COVID-19 (i.e., moderate progressing to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.