Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE), in a news release announced 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 firm advised that it expects that the study will be completed in November 2020 and it anticipates that a planned data readout will be available prior to the end of Q4/20.
The official name of the company's multinational Phase 2b/3 clinical trial is called "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."
Algernon pointed out that the Phase 2b trial calls for the enrollment of 150 patients in total and is already underway. The company commented that if positive preliminary data is recorded in the Phase 2b clinical trial, the study will move directly into a Phase 3 trial. The firm added that the data from the Phase 2b study will determine the precise number of patients required for the Phase 3 trial to reach statistical significance.
The company advised that patients enrolled in the ongoing Phase 2b study are being randomized and treated using an existing standard of care or standard of care plus Ifenprodil in either 60 mg or 120 mg doses three-times daily for two weeks. During the length of the trial, doctors will be observing to see if there are improvements demonstrated across several secondary endpoints. These predefined metrics include blood oxygen levels, time spent in intensive care, time to mechanical ventilation and mortality.
Algernon noted that "NP-120 (Ifenprodil) is a N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) that prevents glutamate signaling." The company stated that NMDA receptors are found on tissues such as lung cells, T-cells and neutrophils. The company believes "Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively." The company stated that the release of cytokines often contributes to the highly problematic cytokine storm that can cause loss of lung function and ultimately death in COVID-19 infected patients.
The company reported that it has filed global intellectual property rights for use of NP-120 (Ifenprodil) in the treatment in respiratory diseases and is currently working on an injectable and slow release formulation.
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