null The RI-MUHC leads new clinical trial of COVID-19 treatment for hospitalized patients
Phase 2 study tests LAU-7b, a Canadian drug with dual antiviral and inflammation-controlling effects
Montreal, December 15, 2020 - The Research Institute of the McGill University Health Centre (RI-MUHC) is currently enrolling patients in RESOLUTION, a multi-centre, randomized, double-blind, placebo-controlled clinical trial of LAU-7b for the treatment of hospitalized COVID-19 patients at higher risk of developing complications because of their age or an underlying condition. The drug acts on lung inflammation and showed potent antiviral effects in-vitro against SARS-CoV-2, the coronavirus responsible for COVID-19. Right now, patients from six hospitals in the province of Quebec can enroll in the trial, and a number of Canadian and U.S. hospitals will be joining in the upcoming weeks.
People with COVID-19 who are very ill experience an exaggerated inflammatory reaction, often referred to as “cytokine storm”, which can lead to a life-threatening pneumonia and acute respiratory distress syndrome (ARDS). Dr. Ramy Saleh, principal investigator of the study, hopes that LAU-7b, a novel oral form of a drug called fenretinide, can stop the inflammatory process and prevent vulnerable patients from experiencing respiratory failure and requiring mechanical ventilation.
“We are looking to enroll approximately 240 hospitalized COVID-19 adult patients who will take either a capsule of LAU-7b or a placebo for a 14-day treatment, in addition to standard care procedures,” says Dr. Saleh, who is a medical oncologist and a researcher at the McGill University Health Centre (MUHC), as well as a trained specialist in clinical trials. “This is a unique study as this is a Canadian drug developed and provided by Laurent Pharmaceuticals, a clinical-stage biopharmaceutical company that spun off from McGill University in 2012.”
“Despite the good news on the vaccine front, research on treatments is still crucial,” adds Dr. Saleh. “Limiting the propagation of the virus will remain a challenge, and we will always have to treat patients who are more vulnerable to developing a severe form of COVID-19. A medication is needed quickly to improve symptoms in admitted patients, shorten their length of stay in hospitals and reduce the burden on our healthcare system.”
A link between cystic fibrosis and COVID-19
Fenretinide is a vitamin A derivative repurposed by Dr. Larry Lands, Director of Pediatric Respiratory Medicine at the Montreal Children’s Hospital of the MUHC and senior scientist at the RI-MUHC and other McGill University and RI-MUHC researchers. They saw its potential to treat the exaggerated inflammatory response that leads to irreversible lung damage in cystic fibrosis (CF) patients – a response that seems similar to the one observed in severe cases of COVID-19.
“Thanks to its inflammation-controlling properties, low-dose fenretinide triggers a natural mechanism – the body’s own resolution of the inflammation process – which keeps the inflammatory response under control without suppressing its protective immune role”, explains Dr. Lands, who is also Chief Medical Advisor for Laurent Pharmaceuticals.
Results from previous studies in adult CF patients showed an important reduction of key pro-inflammatory biomarkers at the onset of a pulmonary exacerbation episodes, suggestive of a protective effect of the drug on the lungs. A Phase 2 North American and Australian clinical trial is currently ongoing with CF patients.
About the RI-MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and healthcare research centre. The Institute, which is affiliated with the Faculty of Medicine of McGill University, is the research arm of the McGill University Health Centre (MUHC) – an academic health centre located in Montreal, Canada, that has a mandate to focus on complex care within its community. The RI-MUHC supports over 420 researchers and close to 1,200 research trainees devoted to a broad spectrum of fundamental, clinical and health outcomes research at the Glen and the Montreal General Hospital sites of the MUHC. Its research facilities offer a dynamic multidisciplinary environment that fosters collaboration and leverages discovery aimed at improving the health of individual patients across their lifespan. The RI-MUHC is supported in part by the Fonds de recherche du Québec – Santé (FRQS). www.rimuhc.ca
McGill University Health Centre
Cell 514 812-7722