Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) said on Tuesday that it has enrolled 75 patients for its multinational Phase 2b/3 human trial of its lead drug NP-120 (Ifenprodil) as a potential treatment for coronavirus (COVID-19) sufferers, which is 50% of its enrollment target.
The Vancouver-based clinical-stage pharma company has been nimble — and unusual — in its hunt for a COVID-19 drug. It has taken a generic neurological drug that Sanofi developed in the 1970’s called Ifenprodil, which is approved for use in South Korea and Japan, and is attempting to repurpose it as a potential COVID-19 treatment.
The company’s current study with a target of 150 patients will be completed by November 2020, with a planned data readout before the end of the fourth quarter this year.
Algernon said the trial has begun as a Phase 2b study of patients and, with positive preliminary data, the clinical trial will move directly into a Phase 3 trial. 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 currently 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 milligrams (taken as one 20 mg tablet three-times daily), or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.
Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, and time spent in intensive care.
Algernon believes that Ifenprodil could reduce the infiltration of neutrophils and T-cells into the lungs, where they can release glutamate and cytokines. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function, and ultimately death, in COVID-19 patients.
Algernon is also steadily advancing its lead drug Ifenprodil as a possible treatment for idiopathic pulmonary fibrosis, acute lung injury, and chronic cough.
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