Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) submitted an investigational new drug application to the US Food and Drug Administration for the next phase of its multinational study of lead drug NP-120, known as Ifenprodil.
The drug, an NMDA receptor antagonist, is a potential therapy for patients with COVID-19, the disease caused by coronavirus.
Ifenprodil could 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, in COVID-19 patients.
READ: Algernon Pharmaceuticals moving closer to Ifenprodil trials for coronavirus treatment as it seeks ethics approval in Australia
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.
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.
Vancouver-based Algernon has already received the go-ahead to commence Phase 2b/3 in Canada and filed for ethics approval in Australia.
“We have already started communicating with a number of US based research institutions in advance, to make sure that we can move quickly with the U.S. part of the clinical trial, if approved,” said Christopher Moreau, CEO of Algernon Pharmaceuticals. “We have identified strong interest to participate in the study and we look forward to starting the trial as soon as possible.”
The company told shareholders that it is not making any express or implied claims that Ifenprodil is effective for the treatment of acute lung injury, COVID-19 or any other medical condition.
Shares of Algernon gained 4.6% on Monday afternoon at C$0.34.
--Updated with share price--
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