Laurent Pharmaceuticals has received Health Canada approval to commence the adaptive Phase II/III ESSOR trial for evaluating the safety and efficacy of LAU-7b in long Covid patients.
The placebo-controlled, randomised study is initiated based on the efficacy and safety profile of LAU-7b, as demonstrated in hospitalised adults with Covid-19.
Inflammation-controlling effects of LAU-7b as a host-directed antiviral were also observed in several preclinical models of respiratory and neurological inflammation.
Funds for carrying out the Phase II portion are provided by the Government of Canada through the National Research Council of Canada (NRC) Industrial Research Assistance Programme (IRAP).
In this portion, 204 adults will be randomised into three study arms. Each arm will receive LAU-7b for three treatment cycles for 12 weeks, on top of the standard of care.
Each treatment cycle will comprise 14 consecutive days in which patients will receive the oral medication once daily at home. They will then be followed by a 14-day drug-free period.
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Measuring the overall functional health status, as evaluated with the physical component score of the SF-36 questionnaire, at week 12 compared to baseline, is the primary endpoint of the study.
Secondary endpoints will assess symptoms and their impact on daily activities using various tests.
They include the FACIT-Fatigue scale, EQ-5D-5L quality of life questionnaire, Likert scale score, DePaul Post-Exertional Malaise Questionnaire, and Patient Global Impression of Change.
Laurent Pharmaceuticals president and CEO Dr Radu Pislariu said: “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.
“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 III clinical development.
“We are also truly grateful to NRC IRAP for supporting our Covid-19 research since the early days of the pandemic.”
LAU-7b is currently being assessed in the RESOLUTION Phase III trial in hospitalised patients with moderate to severe Covid-19.