Laurent Pharma Initiates Phase II Trial of LAU-7b in COVID-19 Disease

Laurent Pharmaceuticals Inc., a Montreal-based biopharma company, received approval from the FDA to start enrolling U.S. patients in RESOLUTION, a multicentric Phase II randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease. RESOLUTION will enroll approximately 200 hospitalized COVID-19 patients who will receive either LAU-7B or a placebo for a treatment duration of 14 days.

LAU-7b, which showed potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses, is also being developed for its 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. The pro-resolving proprieties of LAU-7b are currently under evaluation in a Phase II study in Cystic Fibrosis (CF), aiming to treat the exaggerated inflammatory response that leads to irreversible lung damage in these patients.

The RESOLUTION trial 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.