11 March 2020
GENEVA–(Switzerland)–RELIEF THERAPEUTICS Holding SA (SIX-RLF, “Relief” or the “Company”) announces today that Prof. Jonathan C. Javitt, MD, MPH will be proposed for election as Vice-Chairman of its Board of Directors at the Annual General Meeting to be held on June 19, 2020. Prof. Javitt has already joined Relief Therapeutics’ team as a consultant and his appointment to the Board will allow for the seamless coordination of Relief’s development of RLF-100 (Aviptadil) for the treatment of Acute Respiratory Distress Syndrome (ARDS) in patients infected by the COVID-19 Coronavirus. ARDS is the primary cause of death in those patients who succumb to COVID-19 infection.
RLF-100, acquired by Relief from Mondo Biotech, AG, has an Investigational New Drug (IND) from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to advance in clinical testing and has been awarded orphan drug designation by both agencies for treatment of ARDS, Acute Lung Injury, and Sarcoidosis. Aviptadil is a novel formulation of Vasoactive Intestinal Polypeptide (VIP), a naturally occurring peptide hormone that is known to be concentrated in the lungs after systemic injection. A combination formulation with phentolamine for intracavernous injection has been approved in Europe for treatment of erectile dysfunction, with a 20-year proven record of safety.
Numerous animal studies demonstrate the potential of Aviptadil to reduce lung inflammation in a variety of models and edema. Phase 1b/2 studies in humans, involving a total of 76 patients, have shown that Aviptadil has the potential to reduce bronchospasm under certain circumstances, reduce pulmonary arterial hypertension and treat other features of pulmonary inflammation, including a significant decrease in the pro-inflammatory cytokine tumor necrosis factor alpha (TNF-α). Among them, a Phase 2 pilot trial using RLF-100 in 8 patients with ARDS showed very good safety and encouraging signals suggesting potential efficacy.
“After carefully reviewing the preclinical and clinical data, we believe that RLF-100 has the potential 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, even with ventilation and other acute care respiratory therapy.”
Prof. Javitt has a career-long involvement with the development of lifesaving interventions for public health threats. He served as an advisor in healthcare to four Presidential Administrations (Reagan, Bush ’41, Clinton, and Bush ’43). He joined the administration of President George W. Bush on the afternoon of September 11, 2001 and was subsequently appointed as a Special Employee of the Office of the Undersecretary of Defense. He was also appointed to serve as Senior Fellow of the National Security Health Policy Center of the Potomac Institute for Policy Studies. President Bush subsequently commissioned Javitt to lead the President’s Information Technology Advisory Committee healthcare initiative, which resulted in the establishment of the Office of the National Coordinator for Health IT. In 2016, Javitt was granted the Alumnus of Merit Designation by the Harvard Chan School of Public Health for his work.
“Humanity is threatened by a deadly virus that has demonstrated a propensity to kill up to 3.5% of those infected and 15% of those age 80 and over. Conventional forms for respiratory support have so far failed to preserve life in the majority of those who develop Acute Respiratory Distress that is seen in a minority of those infected.” Commented Raghuram (Ram) Selvaraju, PhD, MBA, Chairman of Relief. “We are cautiously optimistic that the effects of RLF-100 in containing lung inflammation seen in Sarcoidosis and Acute Lung Injury may carry over to the acute lung inflammation seen in COVID-19 patients.”
“Although the vast majority of those infected by COVID-19 survive the disease, those who develop Acute Respiratory Distress Syndrome suffer a mortality rate that is estimated at 30% to 50% with best possible care, said Javitt. It is unclear that sufficient acute care hospital beds exist to support the number of people who might be affected should public health measures fail to contain the epidemic. As such, coronavirus-infected patients who develop ARDS are at particularly high risk. After carefully reviewing the preclinical and clinical data that were submitted to FDA in connection with its review of RLF-100’s IND and Orphan Drug Designation, we believe that RLF-100 has potential to be a safe and effective treatment for ARDS in general and, in particular for COVID-19-induced ARDS. Owing to the rapidly expanding size of the epidemic and the extraordinary unmet medical need, we intend to initiate clinical trials on an urgent schedule in order to bring a potentially life-saving therapeutic to market as soon as possible.”
Although the current epidemic prompts the need to urgently explore and propose rapid solutions aimed at establishing new lines of efficient and safe treatment against COVID-19 and its comorbidities, the timelines to develop an Experimental Medicinal Product into a medicine for prescription to the general population remain long and cumbersome. The demonstration that Aviptadil fulfils the regulatory criteria to become a commercial drug will necessarily follow the authorities’ driven clinical development path even if special adaptation thereof may be envisioned. Relief is confident that it will rapidly compile all necessary information to apply for and receive authorization to test in human the efficacy of Aviptadil in alleviating COVID-19-induced ARDS.
Relief is a company developing drugs via participation in active entities that have obtained intellectual properties through their own research activities or via in-licensing. Development activities of 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 treatment solutions for indications related to diabetic complications and respiratory diseases.
RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP). VIP was originally developed in combination with phentolamine 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. A clinical study evaluating the efficacy of Aviptadil in patients with pulmonary sarcoidosis is currently being conducted by the university of Freiburg, Germany.
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. Ventilation strategies include using low volumes and low pressures. If oxygenation remains insufficient, lung recruitment maneuvers and neuromuscular blockers may be used. The syndrome is associated with a death rate between 35 and 50%. Globally, ARDS affects more than 3 million people a year.
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