RELIEF THERAPEUTICS HOLDING SA (SIX: RLF) Announces Plans to Test Aviptadil for the Treatment of COVID-induced Acute Respiratory Distress Syndrome (ARDS)
RELIEF THERAPEUTICS Holding SA (SIX-RLF, “Relief” or the “Company”) is initiating an urgent phase 2 clinical trial of RLF-100 (Aviptadil) in coordination with the Senior Leadership of the Government of Israel for the treatment of Acute Respiratory Distress Syndrome (ARDS) in patients with COVID-19 infection. The trial is being coordinated by Prof. Jonathan Javitt, MD, MPH, acting Chairman of the Scientific Advisory Board of Relief in coordination with Dr. Miki Halberthal, MD, CEO of the Rambam Healthcare Campus and Dr. Boaz Lev, head of Israel’s COVID task force and former Director General of Israel’s Ministry of Health.
RLF-100, acquired by Relief from Mondo Biotech, AG, has Investigational New Drug clearance from the US FDA and the European Medicines Agency for phase 2 trials in ARDS and has been awarded orphan drug designation by both agencies for treatment of ARDS, Acute Lung Injury, and Sarcoidosis. Aviptadil is Vasoactive Intestinal Polypeptide (VIP), a naturally-occurring peptide hormone that is known to be concentrated in the lungs. VIP has been shown in five species of animal models to have potent effect in models of ARDS and Acute Lung Injury. In these models, Aviptadil has shown potent anti-inflammatory and specifically anti-cytokine activity in the lungs.
The first clinical protocol will compare intravenous administration of Aviptadil to its administration via an endotracheal tube in patients who are already on mechanical ventilation because of ARDS. Assuming no new safety signals are detected, a second protocol will quickly be initiated to treat patients with early signs of respiratory distress in the hopes of preventing progression to ARDS and the need for mechanical ventilation.
“After carefully reviewing the preclinical and clinical data, we believe that RLF-100 has a chance to be a safe and effective treatment for Acute Respiratory Distress Syndrome in patients infected by COVID-19, who otherwise have less than 50% chance of survival, despite intensive care. The State of Israel is eager to test this potentially lifesaving treatment in patients who today have no other therapeutic option, said Dr. Halberthal. We will try every possible mechanism to help safeguard our patients in this global crisis.
“As a third-generation physician and the father of newly-trained physician, I am deeply honored to be working with longtime colleagues in Israel’s Ministry of Health on critical initiative. Owing to the rapidly expanding size of the epidemic and the extraordinary unmet medical need, we intend to initiate phase 2 clinical trials on an urgent schedule in order to bring a potentially life-saving drug to patients.”
RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was originally developed and is currently marketed in Europe for the treatment of erectile dysfunction. VIP is known to be highly concentrated in the lung and to inhibit a variety of inflammatory cytokines. Aviptadil was awarded Orphan Drug Designation in 2001 by the US FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Aviptadil 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 the US FDA and the EMEA have granted Investigational New Drug licenses for human phase 2 trials of Aviptadil.
About Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. Symptoms include shortness of breath, rapid breathing, and bluish skin coloration. Among those who survive, a decreased quality of life is relatively common.
Causes may include viral infection, sepsis, pancreatitis, trauma, pneumonia, and aspiration. The underlying mechanism involves diffuse injury to cells which form the barrier of the microscopic air sacs of the lungs, surfactant dysfunction, activation of the immune system, and dysfunction of the body's regulation of blood clotting. In effect, ARDS impairs the lungs' ability to exchange oxygen and carbon dioxide.
The primary treatment involves mechanical ventilation together with treatments directed at the underlying cause. The syndrome is associated with a death rate between 35 and 50%.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF. For further information, please visit the Relief website at www.relieftherapeutics.com or contact at email@example.com
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
Dr. Yves Sagot
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Nike Extends its Athletic Leadership5.2.2020 19:00:00 CET | Press release
Today, NIKE, Inc. (NYSE: NKE), unveiled breakthrough innovation for athletes competing in the Tokyo 2020 Games, including footwear designed to provide runners with a measurable performance benefit for a new era of competition. The NEXT% platform, introduced by barrier-breaking marathoner Eliud Kipchoge, will now expand into new disciplines following its unparalleled success in distance running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200205005708/en/ An international group of athletes joined the Nike 2020 Forum in New York to unveil the brand's latest performance and sustainable innovations. From left to right: Ibtihaj Muhammad, English Gardner, Leticia Bufoni, Blake Leeper, Timothy Cheruiyot, Dina Asher-Smith, Tomoya Ochiai, Sky Brown, Chris Mosier, Nyjah Huston, DeAnna Price, Bebe Vio, Kevin Mayer, Megan Blunk, Brandi Chastain, Aaron Brown, Sophie Hahn, Aori Nishimura, Diana Taurasi, Miles Chamley-Watson, Leon Schae
Cepton Expands With $50 Million Investment From Koito5.2.2020 18:00:00 CET | Press release
Cepton Technologies, Inc., a leading provider of state-of-the-art, intelligent, lidar-based solutions, announced today that it has raised over $50 million in Series C funding. This brings Cepton’s total funding to nearly $100 million, providing a strong foundation to substantially ramp up its R&D efforts, expand its footprint in the automotive market and support major customers worldwide. The latest funding round was led by Koito Manufacturing Co., Ltd. (TYO:7276), the automotive Tier 1 and world-leading provider of automotive lighting systems, with an investment of $50 million. Existing investors in Cepton also participated in this round. As part of the transaction, Koito will obtain non-exclusive rights to manufacture and sell Cepton’s lidar sensor design for an automotive application, using key components supplied by Cepton. Cepton will use the proceeds to accelerate development and deployment of its advanced lidar technology in ADAS applications, in autonomous vehicle applications,
Imricor Announces First Cases Successfully Performed at Heart Center Dresden5.2.2020 17:40:00 CET | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) is pleased to announce the first procedures using the Company’s products following CE mark of the Vision-MR Ablation Catheter have been performed at the Heart Center Dresden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200205005672/en/ Drs. Christopher Piorkowski (left) and Thomas Gaspar (right) performing iCMR ablations at the Heart Center Dresden (Photo: Heart Center Dresden). Three procedures were successfully performed over two days by Dr. Christopher Piorkowski and Dr. Thomas Gaspar (https://www.herzzentrum-dresden.com/rhythmologie/unser-team/). Additional physicians at the Heart Center Dresden will also begin performing procedures immediately. These procedures mark the first iCMR ablations anywhere in the world to ever be performed outside of a clinical trial. They were performed in an iCMR lab fitted with a Siemens 1.5T MAGNETOM Aera MR scanner. “It’s ano
VALBIOTIS Announces a Global Strategic Partnership With NESTLÉ HEALTH SCIENCE For the Development and Commercialization of TOTUM-63, a Plant-derived Active Substance With Clinically Demonstrated Metabolic Health Benefits on Prediabetics5.2.2020 17:30:00 CET | Press release
Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible ), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the signature of a global long-term strategic partnership with Nestlé Health Science for the development and commercialization of TOTUM-63, an innovative and patented combination of 5 plant extracts specifically designed to reduce the risk of developing Type 2 Diabetes on prediabetics. Sébastien PELTIER, CEO of VALBIOTIS states: “Nestlé Health Science is an ideal strategic partner for VALBIOTIS. Its global reach, strategic intent to develop science-based nutritional health solutions and focus on fighting metabolic disorders like diabetes will be instrumental to TOTUM-63's worldwide commercialization success. We are excited about the opportunity that this deal brings to VALBIOTIS and to the many millions of people around the world at risk of becoming Type 2 diabetics. This trans
Skilling lanserar branschens första sömlösa integration med Spotwares cTrader, inriktad på erfarna handlare.30.1.2020 08:00:00 CET | Press release
Forex- och CFD-handelsplattformen Skilling annonserade förra veckan lanseringen av branschens första sömlösa integration med Spotwares cTrader - en unik funktion som internt kallas Ett konto. Två plattformar. Detta pressmeddelande använder multimedia. Se den fullständiga versionen här: https://www.businesswire.com/news/home/20200130005070/sv/ Skilling lanserar branschens första sömlösa integration med Spotwares cTrader. (Photo: Business Wire) Funktionen gör att Skilling kan erbjuda sina kunder sömlös handel över två olika handelsplattformar på ett enda Skilling-konto utan att behöva finansiera och hantera två olika konton separat. ”Enkelt uttryckt ville vi ge våra kunder valet vilken handelsplattform de kan använda - vår egen Skilling Trader eller en mer avancerad klientorienterad cTrader. Problemet du har med andra mäklare som erbjuder flera plattformar är behovet av att finansiera två konton separat, upprätthålla sunda marginaler på två olika konton och också ha två uppsättningar av
inRiver utser Per-Olof Schroeder till ny VD29.1.2020 16:43:00 CET | Press release
inRiver, som levererar SaaS-baserade lösningar för Product Information Management (PIM), meddelar att styrelsen idag har utsett Per-Olof Schroeder till ny VD för bolaget. Per-Olof tillträder sin tjänst med omedelbar verkan. “Styrelsen tackar Thor Johnson för hans ledning av bolaget under de två senaste åren, och är glada över att välkomna Per-Olof som vår nye VD," säger inRivers styrelseordförande, Jorgen Smidt. "Per-Olof har en påvisad erfarenhet av att mycket framgångsrikt leda utveckling av SaaS Computing Services, molnbaserade tjänster, och samtidigt leverera stark tillväxt både gällande intäkter, lönsamhet och marknadsandelar. I sin roll som bolagets VD kommer han fortsätta att utveckla inRivers mission att hjälpa våra kunder bli bäst på att marknadsföra och sälja sina produkter." Schroeder har mer än 25 års erfarenhet av ledande befattningar inom IT-branchen, inklusive 15 år på Microsoft, varav sju år som chef över Microsofts Productivity & Business Process Business Group i väste
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom