25 May 2020
Geneva, Switzerland: April 7, 2020: 7 am CET
RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” announces that its drug Aviptadil has now entered FDA clinical trials at the University of Miami Miller School of Medicine for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19. The trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lung to transfer oxygen to the body.
The trial is being led by Relief’s US partner, NeuroRx, Inc., Headquartered in Radnor, PA under FDA Investigational New Drug clearance, as part of the FDA’s Corona Treatment Acceleration Program (CTAP). Details are posted on clinicaltrials.gov NCT04311697. The principal investigator for the University of Miami study site is Dr. Dushyantha Jayaweera, professor of medicine. The Co-Principal Investigators are Dr. Daniel H. Kett, professor of medicine, and Dr. Daniel Dante Yeh, associate professor of surgery at the University of Miami Miller School of Medicine. The team will also collaborate with colleagues at the UM Interdisciplinary Stem Cell Institute.
“We are fortunate to have widespread support and collaboration across our institution,” said Dr. Jayaweera. “As we follow rigorous scientific standards, we are cautiously optimistic that the early observations of VIP use in patients with sepsis-related ARDS will carry over to today’s crisis.”
Death in COVID-19-infected patients is caused by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. It has a 20-year history of safe use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction.
Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent for Aviptadil and proprietary manufacturing processes for its synthesis.
“In a previous trial of VIP for ARDS in patients with sepsis, 7 of 8 patients on mechanical ventilation showed substantial improvement and 6 ultimately left the hospital alive,” said Prof. Jonathan Javitt, MD, MPH, the CEO of NeuroRx, Inc.. “Patients on ventilators for COVID-19 have only a 50% chance of survival. If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need.”
The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
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 trials of Aviptadil.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF.
This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. 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 AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG 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.
US 8,178,489 Formulation for Aviptadil