Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) announced Tuesday that it has now enrolled 100 patients, which is two-thirds of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.
The Vancouver-based company said it has projected that the study will be completed in November 2020 with a planned data readout before the end of the fourth quarter of 2020.
Algernon’s multinational Phase 2b/3 human trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease."
READ: Algernon Pharmaceuticals gets green light to continue its Phase 2b/3 coronavirus study from Data and Safety Monitoring Board
The trial has begun as a Phase 2b study of an aggregate of 150 patients. 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, the company said.
Patients are being 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 (mg) (taken as one 20mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120mg (taken as two 20 mg tablets three-times daily) for two weeks.
Over the testing period, Algernon said doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care, and time to mechanical ventilation.
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signaling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.
Algernon said it believes Ifenprodil 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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