In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced it submitted an ethics approval application for a planned multinational Phase 2b/3 study in Australia of its drug NP-120 (Ifenprodil) being repurposed as a potential treatment for COVID-19.
The biopharmaceutical firm made the request of the Princess Alexandra Hospital in Brisbane, Queensland, Australia. Algernon intends to carry out the study in Canada and the U.S. as well, and it already received the go ahead from Canadian authorities. As for the U.S., the company reported it is preparing an investigational new drug application for approval from the U.S. Food and Drug Administration.
Once Algernon has a green light from all three countries, the trial will start as a Phase 2b with 100 patients. Randomized on a 1:1 basis, patients will receive either the standard of care or the standard of care plus 20 mg of Ifenprodil three times a day for two weeks. The trial endpoints will be improvement in mortality, blood oxygen levels, duration in intensive care and time to mechanical ventilation.
If the preliminary Phase 2 results are positive, the study will advance to Phase 3, at which time the number of participants needed will be determined.
The company believes that "NP-120 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 highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients."
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