Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc announced that it has received clearance from the US Food and Drug Administration and its counterparts in Brazil and Mexico to modify the inclusion criteria for its LANCER trial to potentially expedite patient enrollment.
The modifications will allow the enrollment of vaccinated patients, among other things, to broaden the eligible population, according to Oakville, Ontario-based Cardiol.
LANCER is designed to evaluate the efficacy and safety of Cardiol’s flagship drug CardiolRx as a cardiopulmonary protective therapy to reduce mortality and major cardiovascular events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease, and to investigate the impact of CardiolRx on symptom recovery and key biomarkers associated with inflammatory heart disease.
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Eligible patients will now include vaccinated people, those treated with approved COVID-19 therapies under an emergency use authorization label, and patients with a prior history of smoking or obesity.
Cardiol also said it plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers.
The firm told investors it expects Brazil to be a “key contributor” to patient enrollment given the country is approaching its winter season, the pace of vaccine booster administration is slow, and the pre-winter case rate is currently averaging approximately 100,000 per day.
"Given the compelling evidence demonstrating cannabidiol's anti-inflammatory and cardiopulmonary protective properties, we believe CardiolRx has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection,” Cardiol’s chief medical officer Andrew Hamer said in a statement.
“Interest in the LANCER trial remains strong, and Cardiol continues to activate new clinical research sites to accelerate patient recruitment. The repeated waves of COVID-19 outbreaks coupled with inconsistent vaccine and vaccine booster uptake, underscore the need for therapeutics for high-risk patient populations, particularly those with significant CVD risk factors.”
Hamer added that the firm is confident that the recently cleared protocol amendments will help ensure LANCER patient enrollment targets are achieved.
The group expects LANCER to achieve over 50% patient recruitment by mid-2022 and complete full enrollment during the second half of the year.
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