Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) has received US Food and Drug Administration clearance for its planned multinational study of lead drug NP-120, known as Ifenprodil, as a potential therapeutic treatment for patients with the COVID-19 disease.
As part of the multinational Phase 2b/3 clinical study of the repurposed drug, Algernon has already received clearance in Canada and has also filed for ethics approval in Australia.
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.
As an N-methyl-D-aspartate (NMDA) receptor antagonist that targets the NMDA-type subunit 2B (Glu2NB), Ifenprodil prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils.
“We very much appreciated the timely responses that we have received from the US FDA since we first began working with the agency on our COVID-19 clinical trial program,” said CEO Christopher Moreau in a statement Thursday.
“We have already begun the background work to start the Phase 2 trial in the US and other countries as soon as possible and we will update the market shortly on our planned timelines.”
However, the Vancouver-based company cautions that while it is preparing to begin Phase 2 clinical trials shortly, it is not making any express or implied claims that Ifenprodil is an effective treatment for acute lung injury, the COVID-19 disease, or any other medical condition at this time.
Phase 2b/3 will start with an aggregate of 100 patients and, assuming positive preliminary data, will move into Phase 3. The data will determine the number of patients necessary to reach statistical significance.
All patients enrolled in the trial will be randomized in a one-to-one manner and be treated with an existing standard of care. A randomly selected group will also be given a 20-milligram dose of Ifenprodil three times a day over a two-week period. Doctors will observe patient outcomes in a number of categories, such as mortality, blood oxygen levels, length of time in intensive care, and time to mechanical ventilation.
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