Laurent Pharmaceuticals Receives Approval from FDA to Initiate its COVID-19 Phase 2 Clinical Trial in the United States
Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has received approval from the Food and Drug Administration (FDA) to start enrolling U.S. patients in RESOLUTION, a multicentric Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease. RESOLUTION, which is currently ongoing in Canada, will enroll approximately 200 hospitalized COVID-19 patients who will receive either LAU-7B or a placebo for a treatment duration of 14 days. The company is in advanced discussions with a number of U.S. hospitals interested to participate in the trial and is looking to activate them very soon.
"The main objective of the RESOLUTION study is to demonstrate that LAU-7b is a safe and effective treatment option for COVID-19 patients that are at risk of lung complications because of their age, underlying condition or both," said Dr. Radu Pislariu MD, President and CEO of Laurent Pharmaceuticals. "We hope that treatment with LAU-7b will slow down the disease progression, prevent the respiratory failure requiring mechanical ventilation, and ultimately reduce the number of fatalities due to the COVID-19," added Dr. Pislariu.
LAU-7b, which showed potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses, is also being developed for its unique inflammation-controlling properties by acting on the resolution phase of the inflammation process, a natural mechanism that keeps the body's inflammatory response under control without inducing immune-suppression (a "pro-resolving" effect). The pro-resolving proprieties of LAU-7b are currently under evaluation in a Phase 2 study in Cystic Fibrosis (CF), aiming to treat the exaggerated inflammatory response that leads to irreversible lung damage in these patients.
"New clinical research approaches for COVID-19 aim to combine antiviral with inflammation-controlling treatments," said Dr. Dana G. Kissner, MD, pulmonologist at DMC Harper University Hospital and Professor of Medicine, Wayne State University, in Detroit, Michigan. "During the less critical stages of the disease, we want therapies that fight the virus while keeping the inflammation in check and preventing lung complications. LAU-7b appears to possess both properties in the same molecule, thus bearing the promise of a treatment candidate that addresses multiple key contributors to the severity of COVID-19," added Dr. Kissner.
The RESOLUTION trial (Clinicaltrials.gov, #NCT04417257) follows the recommendations of the World Health Organization (WHO) Master Protocol for COVID-19 clinical studies. It will measure the patient health status on a 7-point ordinal scale to evaluate the disease progression and inform the primary and secondary endpoints of the study. The study will also measure the duration of hospitalization and improvement in quality of life.