COVID-19 Clinical Trial Managed by Vantage BioTrials Receives Green-Light from FDA to Proceed in the United States
August 27, 2020, Montréal, Canada – 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.
About Vantage BioTrials
Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory diseases that are inadequately addressed by current anti-inflammatory therapies. The company’s lead drug candidate, LAU-7b, is a unique, patent protected oral formulation of fenretinide, ideally applicable to a once-a-day low dose treatment regimen. LAU-7b has the potential to trigger the resolution phase of inflammation and is currently in a Phase 2 study involving adult patients with CF. Fenretinide also showed potent antiviral effects in vitro against SARS-CoV-2, and the company initiated a Phase 2 clinical trial with LAU-7b in hospitalized COVID-19 patients. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. For more information, please visit www.laurentpharma.com.
About SARS-COV-2 and COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was first identified in December 2019 in Wuhan, Hubei, China, and has resulted in an ongoing pandemic. According to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, as of August 26, 2020, more than 23 million cases have been reported across 188 countries and territories, resulting in more than 820,800 deaths.