Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) said it is seeking ethics approval in Australia for its planned multinational Phase 2b/3 study of its re-purposed drug Ifenprodil for coronavirus (COVID-19).
The pharma group also wants to conduct multinational phase 2b/3 clinical study for the drug in Canada and the USA. It has already received clearance for the clinical study in Canada and is preparing to file an investigational new drug (IND) application with the US FDA, it revealed.
Once all ethics approvals have been received, the trial will begin as a Phase 2b study of 100 patients and with positive preliminary data, the study will move directly from Phase 2b into a Phase 3 trial, Algernon Pharma said.
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 a 20mg dose of Ifenprodil taken three times a day for two weeks.
Algernon believes Ifenprodil, which it discovered has the potential to combat flu, can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively.
These cytokines can result in the so-called cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in coronavirus patients.
"Thanks to the hard work of our CRO partner Novotech, this ethics submission is yet another important step in the company’s COVID-19 clinical development program,” Christopher J. Moreau, CEO of Algernon said in a statement.
"The Algernon team is working hard to finalize the U.S. FDA IND application and will be updating the market on its progress shortly,” he added.
The firm also cautioned in its statement that while it is preparing to begin Phase 2 clinical trials, it is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for acute lung injury (ALI), the COVID-19 virus, or any other medical condition.
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