Therapy Areas: Hereditary Disorders
Health Canada Clears Laurent Pharmaceuticals to Initiate COVID-19 Clinical Trial
6 May 2020 - - Montreal-based biopharmaceutical company Laurent Pharmaceuticals Inc 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 company said.

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.

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.

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.

The RESOLUTION trial follows the recommendations of the World Health Organization 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.

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.

LAU-7b (fenretinide), an investigational synthetic retinoid, has a well-documented safety profile established in 3,000+ patients, in various other indications.