In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that "it has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19."
The firm anticipates that it will complete the study in November 2020 and expects that a planned data readout will be available prior to the end of Q4/20.
Algernon's multinational Phase 2b/3 clinical trial is named "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."
The Phase 2b part of the trial has commenced and calls for the enrollment of 150 patients in aggregate, and, if preliminary data proves positive, the Phase 2b clinical trial will move directly into a Phase 3 trial. The firm stated that Phase 2b study results will determine the exact number of patients required for the Phase 3 trial to reach statistical significance.
The company advised that patients enrolled in the current 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. Throughout the trial, doctors are observing if several secondary endpoints demonstrate improvements. These predefined metrics include mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.
Algernon indicated 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 noted 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 pointed out 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 NP-120 (Ifenprodil) for treatment in respiratory diseases and is presently developing a proprietary injectable and slow release formulation.
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