Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing the first-in-class pro-resolving drug LAU-7b, today announces that it has completed the enrollment for its placebo-controlled Phase 2 RESOLUTION clinical study of hospitalized patients with COVID-19. The study, which enrolled 240 patients across Canada and United States, is expected to report top-line results in Q3 2021.
The main objective of the RESOLUTION study is to determine whether LAU-7b, once-a-day oral administration for 14 days on top of standard of care, can slow down the disease progression, prevent respiratory failure, and ultimately reduce the mortality rate in hospitalized COVID-19 patients.
“We are grateful to the patients, their families, investigators and clinical research staff, for enabling us to reach this important milestone in the clinical development of LAU-7b,” said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. “COVID-19 therapeutics are a vital part in the fight against the infection and its complications, and we remain hopeful that LAU-7b’s dual antiviral and inflammation-controlling properties can provide a viable long-term solution alongside vaccines.”
LAU-7b is a novel oral form of fenretinide, an atypical retinoid that acts on certain cell membrane lipids involved in both viral replication and immune-inflammatory responses. LAU-7b was initially developed for its potential to trigger the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response under control, without inducing immune-suppression (a “pro-resolving” effect). More recently, fenretinide was shown to have antiviral activity in vitro against SARS-CoV-2 and synergistic potential when combined with remdesivir, evocative of different mechanism than typical antivirals.
More details about the RESOLUTION study can be found on www.clinicaltrials.gov using Identifier NCT04417257.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory and fibrotic diseases. 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. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. LAU-7b is currently being evaluated in two Phase 2 clinical trials, in Cystic Fibrosis and COVID-19. For more information, please visit www.laurentpharma.com.