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Sunday, April 18, 2021

Major Run on RLFTF (Relief Therapeutics Holding) On Successful ZYESAMI 2b/3 Trial Results as Submission of Phase 3 data & EUA Looms Large

RLFTF has been moving northbound in a hurry after its partner NeuroRx, Inc. announced the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 has demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen. NeuroRx has signed an agreement to complete a business combination with Big Rock Partners Acquisition Corporation (NASDAQ:BRPA). ZYESAMI™ represents a huge step forward in the fight against covid 19 and EU seems likely now and could be the catalyst that finally ignites RLFTF and propels the stock into a whole new level. Investors are looking for a break over $0.95 highs seen in August for confirmation of the next leg up.  

ZYESAMI™ a synthetic vasoactive intestinal peptide (VIP) is 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. While drugs such as dexamethasone, Remdesivir and Monoclonal antibodies/convalescent plasma have been approved for fighting COVID, these drugs have minimal efficacy, are expensive to produce and difficult to transport. ZYESAMI™ is simple to manufacture and cheap to produce at scale. Another popular synthetic vasoactive intestinal peptide (VIP) is insulin. ZYESAMI™ represents a significant breakthrough in the fight against covid 19 and means there is now an effective therapy for patients in the ICU improving oxygenation, and getting patients out of the hospital faster. Rapid adoption in ICUs nationwide can be anticipated as well as peer reviewed publication of results in the Lancet and other journals. NeuroRx is planning to file for Emergency Use Authorization in this patient population if positive results continue to be demonstrated at day-60 endpoint in line with FDA’s new guidance. Based on the favorable results, one can reasonably conclude the submission of phase 3 data has already occurred to the FDA in anticipation of possible EUA. 

Relief Therapeutics Holding AG (SIX: 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. late-stage clinical trials in respiratory deficiency due to COVID-19. Relief holds a patent issued in the United States and various other countries covering potential formulations of RLF-100™. The Company’s partner NeuroRx draws upon more than 100 years of collective drug development experience from senior executives of AstraZeneca, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on ZYESAMI™, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials.  

ZYESAMI™ a synthetic vasoactive intestinal peptide (VIP), is 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. VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. To our knowledge, other than ZYESAMI™, no currently proposed treatments for Covid-19 specifically target these vulnerable Type II cells. Recent laboratory findings suggest that VIP directly interferes with the spike protein complex of the SARS-CoV-2 virus. 

On February 23 NeuroRx, Inc. announced the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 has demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen. Although not envisioned at the start of the clinical trial, High Flow Nasal Oxygen has become the predominant form of treatment in Covid-19 respiratory failure, with mechanical ventilation reserved for those whose blood oxygen levels cannot be maintained on this less invasive modality. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx in collaboration with RELIEF THERAPEUTICS Holding AG (SIX: RLF; OTCQB: RLFTF). NeuroRx has signed an agreement to complete a business combination with Big Rock Partners Acquisition Corporation (NASDAQ:BRPA). 

Investor sentiment in RLFTF is very high:

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RLFTFThe clinical trial was originally approved as a 28-day study at FDA’s direction. In December, NeuroRx added a 60-day endpoint based on the recognition that the traditional 28-day endpoint adopted in the 1990s for trials in Acute Respiratory Distress Syndrome is not appropriate for critically ill patients with Covid-19, who are frequently maintained in the ICU with advanced technologies well beyond this time point. NeuroRx and other clinical trial sponsors alerted FDA to this trend and yesterday the FDA published formal guidance† changing the required time for measuring the prespecified endpoint of “alive and free of respiratory failure” in critically ill patients to 60 days.  Interim data are being reported because they were unblinded as per the original protocol and the last patient in the trial reached day 60 yesterday. Therefore, study conduct cannot be adversely influenced by release of these interim findings. 

At 28 days, patients treated with ZYESAMI™ demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08). In tertiary care hospitals, ZYESAMI-treated patients were 46% more likely to recover and return home before day 28 (Hazard Ratio controlling for age and severity 1.84; P=.058). Should these trends continue through day 60, they have the potential to reach statistical significance. At day 28, a highly significant 10-day difference in median time to recovery and hospital discharge has emerged in ZYESAMI-treated patients compared to those treated with placebo (P<.006). 

Should the above trends continue through day 60, NeuroRx anticipates filing a request for Emergency Use Authorization in this population of critically ill patients (i.e. those on High Flow Nasal Oxygen) who have exhausted all currently approved treatments. FDA decisions implement a benefit/risk framework. NeuroRx previously announced the high degree of safety observed with use of ZYESAMI.  This safety has continued to be documented in the more than 300 additional patients treated under the Expanded Access Protocol and in patients who have filed requests under the federal Right to Try act. 

The study’s principal investigators, Dushyantha Jayaweera, M.D., FACP (University of Miami), Professors J. Georges Youssef, M.D. (Houston Methodist Hospital), and Richard Lee, M.D. (University of California, Irvine), commented, “We are excited to report that ZYESAMI demonstrates a highly significant reduction in time to recovery compared to patients treated with placebo in those treated with High Flow Nasal Oxygen, together with increased likelihood of recovery and excellent safety. We look forward to learning whether this benefit can also be shown for patients treated with other stages of Covid-19 with inhaled forms of ZYESAMI. We look forward to working with the sponsor to secure emergency use authorization for ZYESAMI in this population of patients.”  

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RLFTF has been moving northbound in a hurry after its partner NeuroRx, Inc. announced the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 has demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen. NeuroRx has signed an agreement to complete a business combination with Big Rock Partners Acquisition Corporation (NASDAQ:BRPA). ZYESAMI™ represents a huge step forward in the fight against covid 19 and EU seems likely now and could be the catalyst that finally ignites RLFTF and propels the stock into a whole new level. Investors are looking for a break over $0.95 highs seen in August for confirmation of the next leg up.   ZYESAMI™ a synthetic vasoactive intestinal peptide (VIP) is 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. While drugs such as dexamethasone, Remdesivir and Monoclonal antibodies/convalescent plasma have been approved for fighting COVID, these drugs have minimal efficacy, are expensive to produce and difficult to transport. ZYESAMI™ is simple to manufacture and cheap to produce at scale. Another popular synthetic vasoactive intestinal peptide (VIP) is insulin. ZYESAMI™ represents a significant breakthrough in the fight against covid 19 and means there is now an effective therapy for patients in the ICU improving oxygenation, and getting patients out of the hospital faster. Rapid adoption in ICUs nationwide can be anticipated as well as peer reviewed publication of results in the Lancet and other journals. NeuroRx is planning to file for Emergency Use Authorization in this patient population if positive results continue to be demonstrated at day-60 endpoint in line with FDA’s new guidance. Based on the favorable results, one can reasonably conclude the submission of phase 3 data has already occurred to the FDA in anticipation of possible EUA. 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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