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Thursday, October 21, 2021

Relief Therapeutics Hldg AG (OTC: RLFTF) Gaining as RLF-100 (aviptadil) Top Line Data Looms

Microcapdaily continues to cover the exciting story of Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) that skyrocketed up the charts earlier this year as its covid-19 treatment RLF-100 (aviptadil) continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. The drug is currently in advanced clinical trials and compassionate use data released earlier this year shows compelling results with a number of covid-19 patients on ventilators returning home in only five days after treatment with RLF-100. According to a recent main stream news article on Fox “Patients had a nine-fold chance of survival and recovery from respiratory failure, after being treated with RLF-100. The drug is simple to manufacture and cheap to produce at scale and if the clinical trials reflect the compassionate use date, RLF-100 should easily get approval from the FDA

Recently speaking to CNBC Relief Chairman Ram Selvaraju said the ongoing Phase 2b/3 trial with RLF-100 is expected to provide topline data in January while attributing the explosive rise in share price to evidence of the efficacy of RLF-100 in “otherwise untreatable patients.” This comes shortly after Relief and its partner NeuroRx, met the 165 enrollment target in ongoing trial of RLF-100, which is a patented version of aviptadil, in critically-ill COVID-19 patients with respiratory failure. Aviptadil is a synthetic form of the human Vasoactive Intestinal Peptide which reduces inflammation in the lungs and protects the alveolar type II cells. Early stage results from expanded access use of RLF-100 have shown a 72% of those that were admitted into the ICU survived. In June, the FDA granted fast-track designation to RLF-100, as well orphan drug tag for acute respiratory distress syndrome.

Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Relief was fonded by former executives of Merck.

Relief’s lead drug candidate RLF-100TM (aviptadil), synthetic vasoactive intestinal peptide (VIP), is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. RLF-100TM is believed to be the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100TM under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100TM. RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.

Relief’s partner; NeuroRx is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca including CEO Dr. Jonathan Javitt who is leading the trial of Aviptadil. Dr. Javitt has an impressive background. He’s the CEO of Neuro-RX, an adjunct professor at Johns Hopkins University and. He has held healthcare leadership roles under four presidents of the United States.Relief is listed on the Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.

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After the recent Extraordinary General Meeting (“EGM”) Relief has elected Tom Plitz as new member of the Board of Directors. Tom is Chief Executive Officer of Chord Therapeutics SA, a privately held biopharmaceutical firm based in Geneva, Switzerland. Peter Egon de Svastich resigned his position as a member of the Board of Relief. The members of the Relief Board of Directors now are Raghuram (Ram) Selvaraju (Chairman), Thomaz Burckhardt and Tom Plitz.  The EGM approved the increase in the compensation pool available for the remuneration of members of the Board of Directors from CHF 1,000,000 to CHF 1,500,000 for the period from the Ordinary General Meeting 2020 until the Ordinary General Meeting 2021. Similarly, an increase in the remuneration of management was approved in the amount of CHF 5,000,000 for the financial year 2021. The EGM approved the modification of the authorized share capital from 1,056,726,052 shares to 1,250,000,000 shares and an increase of the conditional share capital from 740,329,636 shares to 960,000,000 shares. As explained in the EGM invitation, recent issuances of 620,000,000 new shares out of the conditional share capital 3b2 were not yet reflected in the Articles of Association. In addition, 86,658,667 new shares were issued from the conditional share capital 3b2 after publication of the EGM invitation. A total of 706,658,667 shares were already issued prior to the EGM and were therefore included in the increased amount of the conditional share capital 3b2 as set forth in the Articles of Association immediately after the EGM, resulting in an available conditional share capital 3b2 of 253,341,333 shares.

Earlier this month Relief and its partner NeuroRx announced they met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil) for treating Respiratory Failure in patients with Critical COVID-19. Respiratory Failure is defined, according to the FDA, as the need for intensive care with mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in order to sustain adequate levels of blood oxygen.

There is currently no FDA-approved drug that has shown efficacy in patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. In addition to the ongoing phase 2b/3 trial, more than 200 patients with Critical COVID-19 and respiratory failure have been treated in an FDA-approved, Expanded Access Protocol (EAP) for RLF-100™. These patients were unable to enter the phase 2b/3 randomized trial due to severe comorbidities (such as organ transplant, recent heart attack, or cancer). While the companies have focused first on those patients who have no medical alternative and are at immediate risk of death, a phase 2b/3 trial with  RLF-100™ for inhaled use in patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure is expected to start soon.

Although the phase 2b/3 study will remain blinded until the final patients reach day 28, unexpected rapid recovery on chest X-ray has been reported by study sites and frequently reported in the open-label Expanded Access Protocol as well. In the EAP, of the 90 patients who have reached 28 days post-treatment, 72% have survived to day 28.  The clinical trial will continue to enroll patients through the anticipated early Q1 2021 announcement of top line data in order to amass as large a safety database as possible. To date, no drug-related Serious Adverse Event has been reported in any of the ongoing studies of RLF-100, which is consistent with the absence of toxicity seen in extensive nonclinical safety testing and prior human studies.

Prof. Jonathan Javitt, CEO and founder of NeuroRx stated: “Although enrollment has been uniquely challenged by the devastating effects of the pandemic, straining the capacity of hospitals and exposing our investigators and study coordinators to personal peril from COVID-19 in the course of their duties, we are proud to meet our enrollment target as planned. Achieving this milestone in the midst of the pandemic has only been possible because of the extraordinary dedication of the doctors, nurses, pharmacists, and study coordinators who continued to work around the clock to develop this much-needed therapy.

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Microcapdaily continues to cover the exciting story of Relief Therapeutics that skyrocketed up the charts earlier this year as its covid-19 treatment RLF-100 (aviptadil) continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. The drug is currently in advanced clinical trials and compassionate use data released earlier this year shows compelling results with a number of covid-19 patients on ventilators returning home in only five days after treatment with RLF-100. According to a recent main stream news article on Fox “Patients had a nine-fold chance of survival and recovery from respiratory failure, after being treated with RLF-100. The drug is simple to manufacture and cheap to produce at scale and if the clinical trials reflect the compassionate use date, RLF-100 should easily get approval from the FDA. Recently speaking to CNBC Relief Chairman Ram Selvaraju said the ongoing Phase 2b/3 trial with RLF-100 is expected to provide topline data in January while attributing the explosive rise in share price to evidence of the efficacy of RLF-100 in “otherwise untreatable patients.” This comes shortly after Relief and its partner NeuroRx, met the 165 enrollment target in ongoing trial of RLF-100, which is a patented version of aviptadil, in critically-ill COVID-19 patients with respiratory failure. Aviptadil is a synthetic form of the human Vasoactive Intestinal Peptide which reduces inflammation in the lungs and protects the alveolar type II cells. Early stage results from expanded access use of RLF-100 have shown a 72% of those that were admitted into the ICU survived. In June, the FDA granted fast-track designation to RLF-100, as well orphan drug tag for acute respiratory distress syndrome. We will be updating on Relief on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Relief.

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Disclosure: we hold no position in Relief either long or short and we have not been compensated for this article.

Ali Raza
A journalist, with experience in web journalism and marketing. Ali holds a master degree in finance and enjoys writing about cryptocurrencies and fintech. Ali’s work has been published on a number of cryptocurrency publications.

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2 COMMENTS

  1. “The drug is simple to manufacture and cheap to produce at scale…” Theoretically, simple and cheap. But not UNTIL the actual process is developed, proven, approved by FDA (or other relevant supervising agencies), and geared up. Apparently Bachem has sought (or still is seeking) specialized people since the contract(s) were signed, to implement such a process. What can later be described as “simple and cheap”, probably has many costly (in both money and time) steps.
    Note: I am a reader of Yahoo Finance’s RLFTF (ticker symbol) ‘Community’ blog, though the blog includes URL references to other sources, including this website. (And also a concerned investor.)

  2. J’aimerais continuer à suivre l’extraordinaire aventure médicale de cette Société Relief qui, pour moi, représente le seul espoir, pour le moins un espoir majeur, dans la tragédie de cette pandémie.

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