COVID-19 Clinical Trial Managed by Vantage BioTrials Receives Green-Light from FDA to Proceed in the United States
Vantage BioTrials, a full service Contract Research Organization (CRO), has partnered with its biotech Sponsor, Laurent Pharmaceuticals, to lead all clinical trial management activities of their lead oral drug candidate LAU-7b in a multicentric Phase 2 placebo-controlled clinical trial (RESOLUTION) in patients with COVID-19.
We are pleased to join Laurent Pharmaceuticals in announcing that approval has been received 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.
“During these unprecedented times, we are excited to contribute our expertise towards this important initiative for the advancement of effective therapies in patients infected with the novel coronavirus. We look forward to making a positive impact and achieving all study milestones for Laurent Pharmaceuticals”, said Vatche Bartekian, President of Vantage BioTrials. “Our goal and focus is to continue challenging ourselves by providing quality outcomes, strengthening our partnerships with leading North American hospitals who are fighting this devastating disease on the frontlines, and achieving positive clinical trial results. Most importantly, we continue to ensure the safety and well-being of COVID-19 patients through our quality by design and risk-based approach to managing these types of challenging clinical studies”, added Mr. Bartekian.
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.
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.