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Thursday, October 21, 2021

Powerful Run on Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) Phase 2b/3 Trial Top Line Data Coming & ZYESAMI™ (RLF-100TM: aviptadil) Trials

Relief Therapeutics Holding SA (SWX: RLF) (OTCQB: RLFTF) is moving steadily higher on accelerating volume showing an increased level of accumulation and buy volume not seen since the stock was trading at its highs near $1. 2021 is shaping up to be a powerhouse year for Relief who recently successfully concluded their Phase 2b/3 Trial of RLF-100™ for Critical COVID-19 with Respiratory Failure. NCT04311697). No drug-related serious adverse events were reported. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. Top line data are expected in late January – early February 2021. Relief has also been included in ZYESAMI™ (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial.  Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with Critical COVID-19 who are hospitalized or in intensive care units. ZYESAMI™ will be included as one of the first drugs targeting Respiratory Failure in critically ill COVID-19 patients. The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense for investigational drugs capable of targeting the most acutely ill patients with COVID-19.

Microcapdaily continues to report on the latest success of Relief and its covid-19 treatment RLF-100 (aviptadil) which continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. Compassionate use data released late last 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.

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. Its lead drug candidate RLF-100™ (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100™. 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.

Relief and its partner NeuroRx recently concluded their Phase 2b/3 Trial of RLF-100™ for Critical COVID-19 with Respiratory Failure. NCT04311697). No drug-related serious adverse events were reported. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. Top line data are expected in late January – early February 2021. Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “We congratulate NeuroRx on the successful completion of patient enrollment in this crucial pivotal clinical study and look forward to the top line results. Our fervent hope is for RLF-100TM to bring benefit to critically ill patients suffering the consequences of COVID-19 infection.”

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On January 11 the Quantum Leap Healthcare Collaborative of San Francisco announced NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of ZYESAMI™ (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial.  Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with Critical COVID-19 who are hospitalized or in intensive care units. ZYESAMI™ will be included as one of the first drugs targeting Respiratory Failure in critically ill COVID-19 patients.

The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense for investigational drugs capable of targeting the most acutely ill patients with COVID-19.  ZYESAMI™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for the treatment of Critical COVID-19 in patients with Respiratory Failure.

In December 2020, Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, issued a public statement that “Through our Operation Warp Speed partnership, we have worked feverishly with private industry to develop and make treatments available to reduce hospitalization, either shortening the length of stay or treating people with mild or moderate COVID-19 infections before they have to be hospitalized. While we’re making significant progress, treatments to save lives of the sickest patients, such as patients in intensive care or on ventilators, remain an urgent need.”

I-SPY is a platform clinical trial that uses a similar protocol as a traditional clinical trial, but that compares multiple investigational agents combined with a “backbone” of the standard of care.  The trial is designed to rapidly identify those agents that have a large impact on reducing disease severity, including reduced mortality, reducing or avoiding time on ventilation and other longer-term comorbidities. Patients receive one of several products being studied and the results then are compared to the current standard of care.

ZYESAMI™ (RLF-100™: aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has granted IND authorization for intravenous and inhaled delivery of aviptadil for the treatment of COVID-19 and awarded Fast Track designation. ZYESAMI™ is being investigated in two placebo-controlled US phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 300 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ between the two FDA-cleared protocols (randomized and expanded access).

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RLFTF is moving steadily higher on accelerating volume showing an increased level of accumulation and buy volume not seen since the stock was trading at its highs near $1. 2021 is shaping up to be a powerhouse year for Relief who recently successfully concluded their Phase 2b/3 Trial of RLF-100™ for Critical COVID-19 with Respiratory Failure. NCT04311697). No drug-related serious adverse events were reported. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. Top line data are expected in late January – early February 2021. Relief has also been included in ZYESAMI™ (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial.  Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with Critical COVID-19 who are hospitalized or in intensive care units. ZYESAMI™ will be included as one of the first drugs targeting Respiratory Failure in critically ill COVID-19 patients. The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense for investigational drugs capable of targeting the most acutely ill patients with COVID-19. Microcapdaily continues to report on the latest success of Relief and its covid-19 treatment RLF-100 (aviptadil) which continues to show significant potential to treat patients who are already in the Intensive Care Unit (ICU) with Respiratory Failure. Compassionate use data released late last 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. 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.

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