Posted on 08/06/2020 7:53:28 AM PDT by rxsid
FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients
ZURICH — The U.S. Food and Drug Administration has granted NeuroRx Inc Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe COVID-19 to prevent progression to respiratory failure, it and partner Relief Therapeutics Holdings said on Thursday.
...
They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. ... has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.
(Excerpt) Read more at nytimes.com ...
FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients
Human test animals.
Humans have always been test animals, going back to the days of the first to try a bright colored berry on a bush (for example).
They either died, or didn't, and thus began the process of learning what "works" and what doesn't.
The FDA is giving this drug the fast track.
Does this mean it’s still under patent, has no generics, and is very expensive?
Sounds expensive, so I guess it meets all the requirements of a COVID-19 therapeutic.
This is strange. I seem to recall the use of HCQ+ Zinc would prevent the virus from replicating. The HCQ would provide a pathway for the Zinc to enter the cell and thereby prevent replication.
OK, thanks.
Vasoactive Intestinal Peptide (VIP) has been granted Fast Track Designation by FDA for the treatment of Critical COVID-19 with respiratory failure by FDA and has shown initial promise in FDA phase 2/3 clinical trials. Unfortunately, VIP has long been seen as an unattractive candidate for pharmaceutical development owing to its generic status as a natural peptide and its low cost of production, which limit its commercial potential and profitability. VIP may, however, be uniquely attractive from a global health perspective to combat the worst public health crisis since Spanish Flu killed more people than combat during World War I. VIP may also be the only candidate in human trials that could be produced at a cost structure that is compatible with the needs of the developing world.
http://www.freerepublic.com/focus/news/3871736/posts?page=17#17
No, no, no!
Hqc + zinc us too easy and cheap.
Can’t let this crisis go to waste.
Why wouldn’t we allow patients who are at serious risk of death to try whatever they and their doctor think might save their lives? Without significant evidence that it’s going to be harmful, why not give it a shot?
I’m for medical freedom. Individuals should have the CHOICE to decide what is best for their own health and wellbeing in consultation with their doctor without big daddy government stepping in between to decide whether they’re allowed to take risks. If someone is likely to die, let them try anything within reason to live.
PING
FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients
Thanks, rxsid.
Study Description
Brief Summary:
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.
Detailed Description:
Attack of the Alveolar Type II (ATII) cell via its ACE2 surface receptor by the SARS-CoV-2 virus leads to respiratory failure, morbidity, and frequently mortality in COVID-19. There is no approved treatment that specifically targets the pulmonary injury. Vasoactive Intestinal Peptide (VIP) is known to target the VPAC1 receptor of the ATII cell and to 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, a synthetic form of Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and Pulmonary Hypertension and EMEA Orphan Drug Designation for the treatment of ARDS and Sarcoid. RLF-100 (Aviptadil) has been granted FDA Fast Track Designation for the treatment of ARDS/Acute Lung Injury in COVID-19.
The objective of this study is to identify patients with moderate and severe COVID-19 who have not yet developed respiratory failure and to treat them with inhaled Vasoactive Intestinal Polypeptide (VIP) in the hope of preventing progression to Critical COVID-19 with Respiratory Failure.
Nonclinical studies demonstrate that VIP is 70% concentrated in the lung, where it binds primarily to ATII cells. VIP prevents NMDA-induced caspase-3 activation in the lung, inhibits IL6 and TNFα production, protects against HCl-induced pulmonary edema, These and other effects have been observed in numerous animal model systems of lung injury in mice, rats, guinea pigs, sheep, swine, and dogs. In these models, Aviptadil restores barrier function at the endothelial/alveolar interface and thereby protects the lung and other organs from failure.
Both intravenous and inhalation preclinical toxicology and safety pharmacology have been performed in four species, with a six month trial of inhaled RLF-100 in primates.
Aviptadil is approved for human use in Europe and has a demonstrated 20 year history of safety in numerous trials for Sarcoid, Pulmonary Fibrosis, Bronchospasm, Erectile Dysfunction, and a phase I trial in ARDS. In that phase I trial, 8 patients with severe ARDS on mechanical ventilation were treated with ascending doses of VIP. Seven of the 8 patients were successfully extubated and were alive at the five day timepoint. Six left the hospital and one died of an unrelated cardiac event.
Five GCP phase 2 trials of RLF-100 have been conducted under European regulatory authority. Non GCP healthy volunteer studies have shown that i.v. infusion of Aviptadil is well tolerated with few adverse effects including alterations in blood pressure, heart rate, or ECG. In addition to published studies of human use, Aviptadil has been used on a compounded basis in certain ICUs for many years in the belief that it preserves life and restores function in pulmonary hypertension, ARDS, and Acute Lung Injury (ALI).
In this study, patients patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 100 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.
Bkmk COVID
Doctor hopeful inhaled version of drug can combat early-stage coronavirus
Note: The injectable form of RLF-100 is for Wuhan-19 patients who are in serious/critical condition to prevent respiratory failure...while the inhaled version is for earlier/mid disease stage.
Yes, I know, Cavuto is anti HCQ and at least a bit of an anti-Trumper.
Yes, its still under patent. Im not sure about price. Its been around for 18-19 years, so the patent has a year or two left in it. I brought some shares of this co.
This drug shows signs of recover in 3-4 days... the HCQ thing is about 15 days. HCQ has been around what 50 years? RLF-100 hase been around about 18 years.
What’s the ticker symbol?
RLF-100 is probable going to be easy and cheap. Its inhaled, and its been around 18 years. It patients recover in 3-4 day vs 10-15 days for HCQ. Its intended for the very sever cases.
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