In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that "it plans to conduct an interim data review of its multi-national Ifenprodil Phase 2b/3 COVID-19 human study."
The firm stated that the data will be analyzed and centered upon the primary endpoint of the World Health Organization (WHO) ordinal score. The company will also closely review several critical secondary endpoints including the number of days that patients were hospitalized and in the intensive care unit and the number of days patients received oxygen and were placed on mechanical ventilation.
Algernon Pharmaceuticals advised that it expects that the data readout will be ready in less than four weeks from now, during the first week of December 2020. The company indicated that the data presented will pertain to 75 patients on day 15 of the study and will be made available in a descriptive statistics format.
The firm explained that it made the decision to proceed with an enhanced interim data readout due to the recent sharp increase in the number of serious COVID-19 cases recorded around the world. The company added that as several recent adverse events and safety issues have occurred with vaccine and antibody trials, it believes that Ifenprodil offers strong potential for reduction of the severity and duration of COVID-19 infections.
The company's CEO Christopher J. Moreau stated, "With the quickly increasing global threat from COVID-19, we believe we have an obligation to find out now how our COVID-19 trial is trending...If Ifenprodil has been performing well in the study, this early look at the data may allow us to accelerate our COVID-19 program accordingly."
The firm pointed out that Phase 2b trial of hospitalized patients with confirmed COVID-19 disease calls for the enrollment of 150 patients in total and is already underway. The company reported that patients enrolled in the current Phase 2b study are being randomized and treated using an existing standard of care or standard of care plus NP-120 (Ifenprodil) in either 60 mg or 120 mg doses three-times daily for two weeks. The company indicated that if positive preliminary data is recorded in the Phase 2b clinical trial, the study will move directly into a Phase 3 trial.
Algernon explained 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 mentioned that NMDA receptors are found on tissues such as lung cells, T-cells and neutrophils. The company stated it "believes Ifenprodil can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively." The company noted 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 adviseded that it has filed new global intellectual property rights for NP-120 (Ifenprodil) to be used in the treatment of respiratory diseases and that it is currently working on developing both injectable and slow release formulations. Algernon Pharmaceuticals stated that at present it is not making claims of any kind regarding the ability of Ifenprodil to contain, cure or eliminate SARS-CoV-2.
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