Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) reported more positive news on its multinational Phase 2b/3 human study of Ifenprodil to treat coronavirus (COVID-19).
In a statement on Wednesday, the drug repurposing firm said the external data and safety monitoring board (DSMB) had unanimously approved the continuation of the study.
"We are very pleased with the unanimous decision of the DSMB to carry on with the study," said Christopher J. Moreau, chief executive officer of Algernon Pharmaceuticals.
"It confirms what we had previously identified regarding Ifenprodil’s long-standing safety history."
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.
With positive preliminary data from the Phase 2b study of a total of 150 patients, the clinical trial will move directly into Phase 3.
The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
Patients are 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.
Algernon said it would update on a projected completion date of the study, as well as when the read-out of the data can be expected when enrollment in the study reaches 50%.
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