Geneva, Switzerland: March 17, 2020: 7 AM
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.
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%.
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