RLFTF A promising anti-COVID drug you have probably never heard of Alex Schroeti Aug 20 · 5 min read This drug is 50 years old and no, it’s not hydroxychloroquine. Image for post Chemical structure of Aviptadil, taken from Wikipedia.org Aviptadil, Relief Therapeutics, or NeuroRx, do these names sound familiar to you? Probably not. Yet, they could become known globally if the clinical studies in Phase IIb/III give good results. There are reasons to be hopeful and here is why. How COVID-19 attacks the body COVID-19 attacks type 2 alveolar cells (AT-II) in the lungs, intruding by binding to ACE2 receptors on the AT-II cells. Once inside, COVID-19 replicates millions of viral particles, ultimately causing cell rupture; These AT-II cells are key to protecting the ability of the lung cells to engage in the gas transfer process, getting oxygen into the bloodstream, by secreting pulmonary surfactant, lowers surface tension at the air/liquid interface within the alveoli, which protects the alveoli during the crucial oxygen transfer process and prevents the alveoli from collapse. The destruction of these AT-II lung cells by COVID-19 reduces the production of pulmonary surfactants, decreasing lung function because oxygen is no longer being transferred into the blood, and carbon dioxide is no longer being transferred out of your lungs by the alveoli. [Gas Exchange summary video]. This gas exchange is essential for survival. COVID-19’s occupancy of the ACE2 receptor might also affect Angiotensin II conversion, increasing vasoconstriction and blood pressure, and cytokine release from angiotensin receptor (ATR-1) expressing cells. The Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, which is the body’s out-of-control immune system activation as a result of the COVID-19 invasion, further weakens the walls of blood cells and allows for leakage of fluids into the lungs, causing the lungs to fill with fluid (pulmonary edema). Pulmonary edema further incapacitates the alveoli and prevents normal oxygen transfer. To summarize, the SARS-CoV-2 virus directly targets and incapacitates certain lung cells. This can create a domino effect of severe trauma to the lungs, and trigger an out of control immune system response which can further exacerbate the trauma. Every day, scientists discover new facts about this virus and this is a simplification of the (very) complex mechanism with which we get infected. The Drug RLF-100™, also known as Aviptadil, is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) patented by Relief Therapeutics, a Swiss biotech company. RLF-100™ has been granted Fast Track Designation and is currently in phase 2/3 placebo-controlled trials (NCT04311697). FDA has granted Emergency Use IND and Expanded Access Protocol approval NCT04453839 for the use of RLF-100™ in patients whose comorbidities render them ineligible for inclusion in the ongoing pivotal trial. These comorbidities, predictive of poor outcomes in COVID-19, were deemed to be sufficiently rare that enrollment could not adequately be balanced within the structure of the randomized trial. VIP is an endogenous polypeptide, meaning it originates within the human body. A polypeptide is generally a large number of amino acids bonded together in a chain, to form a substance such as a protein. VIP : suppresses replication of the SARS-CoV-2 virus in human lung cells; prevents damage to the lung alveoli gas exchange process; upregulates the surfactant production ability and epithelium replenishment ability of the AT-II cells, protecting lung cells from damage; prevents hypertension and vasoconstriction that leads to alveoli cell wall weakening and pulmonary edema; Potentially vital to the effects of RLF-100™ is that it inhibits various pro-inflammatory cytokines in the lungs, possibly halting and/or reversing the cytokine storm. RLF-100 also reverses the CD4/CD8 ratio, which is a measure of the strength of the immune system. Relief Therapeutics has partnered with a private U.S.-based company, NeuroRx, to conduct two multicenter, quadruple masked, placebo-controlled clinical trials in patients with lung injury associated with COVID-19, with an expanded access compassionate use “trial”: 1. Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV) (NCT04311697), Estimated Completion Date: September 2020 2. Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19 (AVINALI) (NCT04360096), Estimated Study Completion Date: October 1, 2020 3. RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) (SAMICARE) (NCT04453839) The last trial is the one I want to talk about. The Results Trial 3 includes a series of 21 consecutive patients with Acute Respiratory Failure in Critical COVID-19 and multiple co-morbidities, treated with intravenous VIP. So far, 19 out of 21 of them have survived. At the moment, August 20, 7 patients were discharged from the hospital, 7 sent to intermediate care, and 5 remain in the ICU. As often in those cases, blood oxygenation is very low and can be lethal. As you can see below, the use of RLF-100™, dramatically improved blood oxygenation. Image for post The results are statistically significant, so there are reasons to be hopeful to receive good news when the next clinical results will come in. As anecdotal evidence, a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days. In a recent interview, Raghuram Selvaraju, Chairman of Relief Therapeutics, estimated that “ I would say the probability at the moment stands at 60 to 70% that we will get the drug approved.” https://medium.com/@alexschroeti/a-promising-anti-covid-drug-you-have-probably-never-heard-of-d6cae8072da6 .
Trial 3 includes a series of 21 consecutive patients with Acute Respiratory Failure in Critical COVID-19 and multiple co-morbidities, treated with intravenous VIP. So far, 19 out of 21 of them have survived. At the moment, August 20, 7 patients were discharged from the hospital, 7 sent to intermediate care, and 5 remain in the ICU. As often in those cases, blood oxygenation is very low and can be lethal.
As you can see below, the use of RLF-100™, dramatically improved blood oxygenation.
A promising anti-COVID drug you have probably never heard of
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