FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure – Yahoo Finance

Before this acute stage, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are understood to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the path of entry for the SARS-CoV-2 into the cells. These exact same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces providing rise to the hypothesis that VIP might particularly safeguard these cells from injury.Injury to the type 2 alveolar cells is a progressively possible system of COVID-19 illness development (Mason 2020). These specialized cells renew the more typical type 1 cells that line the lungs. Type 2 cells make surfactant that coats the lung and is necessary for oxygen exchange.

– Aviptadil is now shown as the first COVID therapeutic to obstruct replication of the SARS-CoV-2 virus in human lung cells and monocytes, while likewise preventing synthesis of cytokines in the lung- RLF-100 is a patented formulation of aviptadil (artificial human Vasoactive Intestinal Polypeptide, VIP), which has been approved FDA Fast Track Designation, FDA emergency situation use IND permission, and an expanded access protocol.RADNOR, Pa. and GENEVA, Aug. 6, 2020/ PRNewswire/– NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX: RLF, OTC: RLFTF) “Relief” today revealed that NeuroRx has actually been approved Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled usage in clients with extreme and moderate COVID-19 in order to prevent development to breathing failure.The study is published at https://clinicaltrials.gov/ct2/show/NCT04360096.  The very first stage will commence with clients hospitalized for extreme COVID-19 who do not yet have breathing failure. If appealing results are seen in the inpatient setting, the trial will broaden to patients at house with moderate and moderate COVID-19 in order to prevent the requirement for medical facility admission.Professor Jonathan Javitt, MD, MPH, CEO of NeuroRx stated, “Now that we understand VIP suppresses replication of the SARS-CoV-2 infection in human lung cells, based upon the impressive work of the Oswaldo Cruz Institute (Rio de Janeiro).1 We are positive that treatment with VIP will not only assist clients on ventilators, however will help to stop the improvement of the virus in patients with earlier phases of COVID-19. By obstructing cytokine synthesis in the lung cells and increasing the production of surfactant, which is essential to the lungs capability to transfer oxygen, we are hopeful that inhaled VIP will show to be of medical benefit across a larger variety of patients suffering breathing problems from COVID-19 infection.” The scientific trial of the inhaled formulation of RLF-100 is anticipated to start on or prior to September 1, 2020. About VIP in Lung InjuryVasoactive Intestinal Polypeptide (VIP) was very first discovered by the late Dr. Sami Said in 1970. Very first identified in the digestive system, VIP is now known to be produced throughout the body and to be mostly concentrated in the lungs. VIP has actually been revealed in more than 100 peer-reviewed research studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, intense lung injury, and swelling. Most importantly, 70% of the VIP in the body is bound to an unusual cell in the lung, the Alveolar Type II cell, which is crucial for the transmission of oxygen to the body. VIP has a 20-year history of safe usage in humans in several human trials for sarcoidosis, lung fibrosis, asthma/allergy, and lung hypertension.COVID-19-related death is mostly triggered by respiratory failure. Before this intense phase, however, there is proof of early viral infection of the alveolar type 2 cells. These cells are understood to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which function as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are revealed to reproduce in alveolar type 2 cells, but not in the more many type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surface areas triggering the hypothesis that VIP could specifically safeguard these cells from injury.Injury to the type 2 alveolar cells is a significantly plausible system of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. Type 2 cells make surfactant that coats the lung and is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.About RLF-100RLF-100 (aviptadil) is a trademarked solution of Vasoactive Intestinal Polypeptide (VIP) that was established based upon Dr. Saids initial work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is known to be highly concentrated in the lungs and to inhibit a variety of inflammatory cytokines. Reliefs predecessor company, Mondo Biotech, was awarded Orphan Drug Designation in 2001 by the U.S. FDA for aviptadil in the treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Mondo was awarded Orphan Drug Designation by the European Medicines Agency in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis. Both Mondo and Relief have actually dealt with advancement of an inhaled formulation of aviptadil for numerous years. Both the U.S. FDA and the EMEA have actually given Investigational New Drug licenses for human trials of aviptadil.Story continuesAbout RELIEF THERAPEUTICS Holding AGThe Relief group of companies focus mostly on clinical-stage projects based upon molecules of natural origin (proteins and peptides) with a history of scientific screening and use in human patients or a strong scientific rationale. Currently, Relief is focusing its efforts on developing brand-new treatments for respiratory illness indications.Relief Therapeutics holds orphan drug classifications from the U.S. Food and Drug Administration and the European Union for making use of VIP to treat ARDS, lung high blood pressure, and sarcoidosis. Relief Therapeutics also holds a U.S. patent (US8178489 formula for aviptadil) for RLF-100 and proprietary manufacturing processes for its synthesis.RELIEF THERAPEUTICS Holding AG is noted on the SIX Swiss Exchange under the sign RLF.About NeuroRx, Inc.NeuroRx brings into play more than 100 years of collective drug advancement experience and is led by previous senior executives of Johnson & & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has actually been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials. Its Board of Directors and Advisors consists of Hon. Sherry Glied, previous Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, previous President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, previous Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.Disclaimer: This interaction specifically or implicitly contains certain forward-looking declarations worrying RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their services. Such statements involve particular recognized and unidentified dangers, uncertainties and other elements, which might cause the actual results, monetary condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or accomplishments expressed or indicated by such positive declarations. RELIEF THERAPEUTICS Holding AG is offering this interaction as of this date and does not undertake to upgrade any forward-looking statements included herein as an outcome of brand-new info, future events or otherwise.CORPORATE CONTACTSUS InquiriesJonathan C. Javitt, M.D., MPHChief Executive OfficerNeuroRx, Inc.ceo@neurorxpharma.comEurope InquiriesYves Sagot, Ph.D.Chief Scientific OfficerRelief Therapeutics Holding AGyves.sagot@relieftherapeutics.comMEDIA CONTACTUS – David SchullRusso Partners, LLCdavid.schull@russopartnersllc.com 858-717-2310Europe – Raimund Gabriel, Laurie DoyleMC Services AGNeurorx@mc-services.eu +49 89 210 228 0INVESTOR RELATIONSBrian KorbSolebury Troutbkorb@troutgroup.com 917-653-5122 View original content: https://www.prnewswire.com/news-releases/fda-grants-inhaled-use-ind-for-rlf-100-aviptadil-to-treat-patients-with-moderate-and-severe-covid-19-aiming-to-prevent-progression-to-respiratory-failure-301107288.htmlSOURCE NeuroRx, Inc; Relief Therapeutics Holding AG

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