Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF), the drug repurposing company, told investors Wednesday it has now enrolled a third of the patients it is targeting for its multinational Phase 2b/3 human study of Ifenprodil to treat coronavirus (COVID-19) - namely 50.
The trial will begin as a Phase 2b study of using a total of 150 patients. If there is positive preliminary data, it will move directly into a Phase 3 trial.
Data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
"We are very pleased with the enrollment rate considering we started the study less than 30 days ago,” said Christopher J. Moreau, the CEO of Algernon Pharmaceuticals in a statement. "We should see an increase in the number of patients enrolling per week as the study progresses."
Algernon believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the so-called cytokine storm contributing to the loss of lung function and ultimately death as has been reported in coronavirus (COVID-19) patients.
The biotech group said it would update the market on a projected completion date of the study as well as when the readout of the data can be expected when enrollment in the study reaches 50% of the target level (75).
In the Phase 2b/3 study, patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20mg tablet three times a day) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three times daily) for two weeks.
Doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.
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