In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that it has "enrolled its first patient from the U.S. for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19."
The firm advised that the Phase 2b/3 trial calls for the enrollment of 150 patients in total from all participating sites and that it has already enrolled 26 patients since the study commenced on August 5, 2020.
Algernon CEO Christopher J. Moreau stated, "We are very pleased to announce our first U.S. patient...We have also had steady enrollment from one of our international sites and as a result, we expect to reach 25% of our total target shortly."
AlgernonPharmaceuticals stated that its multinational human 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 plans for the enrollment of 150 patients and if positive preliminary data is demonstrated, the clinical trial will move directly into a Phase 3 trial. The company said that Phase 2b study results will dictate the number of patients required for the Phase 3 trial in order to reach statistical significance.
Patients in the study will be randomized and be treated using an existing standard of care or standard of care plus Ifenprodil in either 60 mg or 120 mg doses for two weeks. During the trial, doctors will observe if there are improvements in several secondary endpoints including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.
Algernon noted that it plans to provide an update in the near future as to the study's projected completion date along with details as to when the read out of the data will be available.
The firm explained that NP-120 (Ifenprodil) is "a N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) which prevents glutamate signaling." The company added that NMDA receptors are found on various 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."
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