MONTREAL– 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).
« We are really eager about the prospect of applying LAU-7b’s dual antiviral and inflammation-controlling properties against Long COVID, a disease that has such a devastating impact on patient’s quality of life » said Dr Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. « 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. We are also truly grateful to NRC IRAP for supporting our COVID-19 research since the early days of the pandemic », added Dr Pislariu.
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.
« For COVID long-haulers, the pandemic is far from over, many are suffering from the long-term consequences of this infection and we need something to help these people », said Dr Alain Piché, M.D. FRCPC, microbiologist and infectious-disease specialist, Professor at the Université de Sherbrooke and Lead Investigator for the ESSOR trial at the CIUSSS de l’Estrie-CHUS’ Long COVID clinic. « Unfortunately, I’m seeing too many such patients, it takes a toll on their daily lives and there is not very much we can do to help them besides trying to ease some of the symptoms. We welcome such efforts from the industry to develop dedicated treatments for this complex condition that ultimately could have a significant impact on the life of these individuals and the society », added Dr Piché.
LAU-7b is developed as a host-directed oral once-a-day COVID-19 therapeutic targeting host cells membrane lipids to exert dual antiviral and inflammation-controlling activities. SARS-CoV-2 must reprogram host cellular lipid metabolism to favor its entry and replication, a mechanism shared by all lipid-enveloped viruses. Fenretinide, the active ingredient in LAU-7b, works by modulating host cell membrane lipids and de-novo cell lipogenesis needed for virus replication. Because it acts on the host rather than the virus, LAU-7b has potential for broad-spectrum antiviral activity regardless of mutations, as already demonstrated in-vitro on multiple coronavirus variants. Fenretinide was also shown to trigger certain membrane phospholipids metabolic pathways involved in the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response under control without inducing immune-suppression.
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.
