Relief Therapeutics (OTC:RLFTF) RLF-100 Aviptadil can potentially cure COVID-19 patients which makes it bigger than Pfizer (PFE) and Moderna (MRNA). Aviptadil is a synthetic form of Vasoactive Intestinal Peptide (VIP) consisting of 28 amino acids which was first discovered in 1970. Although initially identified in the intestinal tract, human VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. The drug is in Phase 2b/3 trial.
Why RLF-100 is bigger than Pfizer and Moderna’s vaccine
Relief Therapeutics’ RLF-100 has been in the market for over 20 years with a history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension. RLF-100 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 people are calling the vaccine from Pfizer and Moderna a rushed vaccine. People in some cases are saying they would not take a rushed vaccine due to the side effects that may pop up later within 5 years.
Despite Dr. Fauci’s word about the vaccines not being rushed people are still contemplating on whether to take it or not.
RLF-100 is safer than vaccines
In the open-label prospective study, more rapid recovery was seen among 21 patients treated with RLF-100 than those treated with standard of care with an average of nine fewer ICU days in the RLF-100 treated patients compared to those treated with Standard of Care.
“Should RLF-100™ prove to be safe and effective for treating COVID-19 Respiratory Failure, the nation will owe an eternal debt of gratitude to the front-line healthcare workers, technicians, study coordinators, nurses, and doctors who worked seven days a week to help develop this treatment while risking their own health to do so. They are the true heroes.”Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc
RLF-100’s Phase 2b/3 Trial
RLF-10 is being investigated in two U.S. Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. These two trials will evaluate the curative and protective effect of RLF-100™ on COVID-19-induced ALI in both critical and moderate to severe patients.
Topline data from the intravenous study is expected Q4 2020, with topline data from the inhaled study anticipated in H1 2021. Relief is currently preparing a European phase 2b/3 study with RLF-100™ in COVD-19 patients.
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)
- Novel Corona Virus (SARS-CoV-2) is 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 Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
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 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 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.
RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) (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 who 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.
Is Relief Therapeutics’ RLF-100 a great investment?
Yes, among the midst of most Americans not comfortable of taking a potentially rushed vaccine, RLF-100 can become a huge play among vaccines such as Pfizer and Moderna. Vaccines are not made for everyone.
RLF-100 or Aviptadil has data going back decades, has shown this drug to be highly effective. The company is developing it for use in severe COVID-19 patients.
Their drug candidate works by using a multimodal mechanism of action that uniquely target the pathways (inhibition of viral replication, deterrence of inflammatory cytokines, prevention of cell death and upregulation of surfactant production) attacked by the SARS-CoV-2 virus (COVID-19), preventing acute lung injury (ALI) which potentially can stop the replication of the virus.
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