Pharma Focus Europe

Laurent Pharmaceuticals Receives Approval From Health Canada to Commence Phase 2/3 Clinical Trial for Long COVID

Wednesday, August 30, 2023

Laurent Pharmaceuticals Inc., headquartered in Montreal, has received approval from Health Canada to initiate the ESSOR trial – a Phase 2/3 randomized placebo-controlled study. This trial will investigate their oral drug candidate, LAU-7b, as a potential treatment for Long COVID. The initial phase will involve 204 adult patients with moderate to severe Long COVID, supported financially by the Canadian Government through the National Research Council of Canada (NRC) Industrial Research Assistance Program (IRAP).

Dr. Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals, expressed enthusiasm about applying LAU-7b's dual properties – its antiviral and inflammation-controlling effects – to address the substantial impact of Long COVID on patients' lives. Dr. Pislariu also connected the ESSOR study to their ongoing evaluation of LAU-7b as an advanced COVID-19 therapeutic. This drug had shown positive results in patients with acute COVID-19 infection and is now progressing to Phase 3 clinical development. He extended gratitude to NRC IRAP for their support during the early stages of the pandemic.

LAU-7b is described as a host-directed oral COVID-19 therapeutic. Its mechanism involves inhibiting the virus's access to crucial host cell membrane lipids required for entry and replication. Additionally, LAU-7b has shown promise in mitigating acute and chronic inflammation in the lungs and brain – organs significantly affected in individuals with Long COVID. The drug is concurrently undergoing assessment in the RESOLUTION Phase 3 trial for hospitalized patients with moderate to severe COVID-19. In the Phase 2 pilot segment of RESOLUTION, LAU-7b demonstrated a remarkable 100% reduction in the risk of progressing to mechanical ventilation or death when compared to a placebo.

Dr. Alain Piché, an infectious diseases specialist, emphasized the prolonged challenges faced by COVID long-haulers and underlined the crucial need for dedicated treatments for this intricate condition.

Developed as a once-daily COVID-19 therapeutic, LAU-7b targets host cell membrane lipids to provide both antiviral and inflammation-controlling effects. Its active component, Fenretinide, modulates these lipids and the cell's lipogenesis process necessary for virus replication. Notably, LAU-7b's action is directed at the host, granting it the potential for a broad-spectrum antiviral effect unaffected by mutations. Additionally, it stimulates specific metabolic pathways associated with membrane phospholipids, facilitating the natural resolution of inflammation without causing immune suppression.

The ESSOR trial is a randomized, placebo-controlled Phase 2/3 clinical study designed to evaluate the safety and efficacy of LAU-7b as a potential remedy for Long COVID. The primary objective is to alleviate the disease's impact on patients' daily activities. Building on the established efficacy and safety profile of LAU-7b in COVID-19 patients, as well as its promising preclinical characteristics, the trial's Phase 2 portion will involve 204 adults with moderate to severe Long COVID. Primary and secondary endpoints encompass functional health status, symptom evaluation, and their overall influence on daily life. For detailed trial information, interested parties can refer to using Identifier NCT05999435.

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