- The ESSOR study is a natural extension to our ongoing evaluation of LAU-7b as a next-generation COVID-19 therapeutic, which generated positive results in patients with acute COVID-19 infection and is now in Phase 3 clinical development
MONTREAL, QC, Canada – August 29th, 2023 – Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has obtained the approval from Health Canada to initiate ESSOR, an adaptive Phase 2/3 randomized placebo-controlled trial testing its oral drug candidate LAU-7b as a potential treatment for Long COVID. The Phase 2 portion, which will involve 204 adult patients with moderate to severe Long COVID, is conducted with financial support from the Government of Canada via the National Research Council of Canada (NRC) Industrial Research Assistance Program (IRAP).
LAU-7b is a host-directed oral COVID-19 therapeutic that works by stopping the virus access to host cell membrane lipids needed for its entry and replication, and was also shown to have a pro-resolution effect on both acute and chronic inflammation in the lungs and brain, two of the most affected organs in patients with Long COVID. LAU-7b is currently being evaluated in the RESOLUTION Phase 3 trial involving hospitalized patients with moderate to severe COVID-19. Results from the RESOLUTION Phase 2 pilot portion showed a 100% reduction in the risk of progression to mechanical ventilation or death in this patient population, LAU-7b relative to placebo.
About ESSOR Phase 2/3 clinical trial
ESSOR is a randomized, placebo-controlled, Phase 2/3 clinical trial evaluating the efficacy and safety of LAU-7b as a potential treatment for patients with Long COVID, aiming to reduce the overall disease burden on performance of daily activities. The trial builds on the known efficacy and safety profile of LAU-7b in hospitalized adults with COVID-19, as well as on the preclinical evidence of LAU-7b as a host-directed antiviral with inflammation-controlling effects in several preclinical models of respiratory and neurological inflammation. The ESSOR Phase 2 portion will enroll 204 adults with moderate to severe Long COVID, randomized in three (3) study arms, each receiving the study medication for three (3) treatment cycles for a total duration of 12 weeks, on top of standard of care. Each treatment cycle will consist of 14 consecutive days of once-a-day oral study medication self-administered at home, followed by a 14-day drug-free period. The primary endpoint will measure the overall functional health status evaluated with the physical component score (PCS) of the SF-36 questionnaire at Week 12 compared to baseline. Secondary endpoints include evaluation of symptoms and their impact on daily activities using various tests such as the Patient Global Impression of Change (PGI-C), FACIT-Fatigue scale, the DePaul Post-Exertional Malaise Questionnaire, the EQ-5D-5L quality of life questionnaire, and Likert score. More details about the ESSOR clinical trial can be found on www.clinicaltrials.gov, using Identifier NCT05999435.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biotech company focusing on the modulation of cell membrane lipids for addressing life-threatening diseases. The company’s lead drug candidate, LAU-7b, is a proprietary oral formulation of fenretinide, an atypical retinoid with a well-documented safety profile established in more than 3,000 patients. Existing data suggest that low-dose fenretinide has the potential to modulate certain membrane lipids and exerts antiviral, inflammatory-controlling, and antifibrotic properties. LAU-7b is currently being evaluated as a potential therapeutic for COVID-19 and Cystic Fibrosis. For more information, please visit www.laurentpharma.com.
