MONTREAL— Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has obtained the approval from Health Canada to initiate RESOLUTION, a Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential drug candidate to help combat the COVID-19 disease. The trial, which is planned to start imminently in multiple hospitals in Canada, will enroll approximatively 200 hospitalized COVID-19 patients for a treatment duration of 14 days.
« We are really pleased by the expedited review by Health Canada and we are working closely with clinical sites in Montreal to start enrolling the first patients very soon,» said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. The objective of the treatment is to reduce the severity of the disease and prevent its progression towards an acute respiratory failure known as the Acute Respiratory Distress Syndrome (ARDS). Ultimately, we hope the medication could help in keeping hospitalized patients off ventilators, » added Dr Pislariu.
Laurent Pharmaceuticals is developing LAU-7b for its capacity to trigger the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response of the body under control without interfering with its immune role (a “pro-resolving” effect). LAU-7b is believed to interfere with coronavirus replication and host avoidance by acting on the same lipid-modulating pathways it uses for the pro-resolving effect.
« Many patients who have contracted the COVID-19 virus suffer from complications of an inflammatory response that gets out of control. Inflammation is needed to fight infection but, sometimes, the body’s ability to control an inflammatory response may be affected with age or underlying conditions, leading to an overwhelming and self‐perpetuating pro-inflammatory environment, » said Dr. Larry Lands, Pneumologist at McGill University Health Center. « Typical anti-inflammatory drugs work by inhibiting the activation mechanisms of the inflammation process, which are also necessary and important for starting the immune defense. As opposed to these drugs, LAU-7b stimulates the natural resolution mechanisms and let’s the body decide when to reduce inflammation – a more biological way to maintain an efficient yet harmless immune-inflammatory balance, » added Dr. Lands.
The RESOLUTION trial follows the recommendations of the World Health Organization (WHO) Master Protocol for COVID-19 clinical studies and will measure the patient health status on a 7-point ordinal scale as primary outcome. Secondary outcomes include various measurements of disease progression, duration of hospitalization and quality of life.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on severe inflammatory diseases that are poorly addressed by current anti-inflammatory therapies. The company’s lead drug candidate, LAU-7b, is a unique, patent protected once-a-day oral formulation of fenretinide with high bioavailability 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 Cystic Fibrosis (CF). LAU-7b (fenretinide), an investigational synthetic retinoid, has a well-documented safety profile established in 3,000+ patients, in various other indications. For more information, please visit www.laurentpharma.com.
May 06, 2020