In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that "it has now enrolled 154 patients in its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19."
The company stated that although it reached its target of 150 patients in the study, it has decided to raise that number to 168 to allow for normal attrition that often occurs throughout the course of clinical trials. The company plans to add 14 patients above the current enrollment. Algernon Pharmaceuticals noted that it will close out enrollment when it reaches 168 total patient subjects.
The company's CEO Christopher J. Moreau commented, "We are almost there in terms of completing patient enrollment. Sometimes when a study has a group that does not receive the treatment drug, you see a higher percentage of patients dropping out, than is typically seen. By adding approximately 12% to the original target total of 150 patients, we should be able to ensure we achieve the proper study size to power our data calculations."
The firm indicated that "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" is underway and reported that patients enrolled in the study are being randomized one-to-one 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. The firm advised that "over the testing period, 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."
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."
Algernon Pharmaceuticals expressly 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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