Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced in a news release that "it expects to report its topline results for the Phase 2b part of its Phase 2b/3 COVID-19 trial of Ifenprodil, in the last week of March 2021."
The firm advised that independent statisticians will be the only parties having access to the data from the study while it is being compiled and analyzed. The company noted that after it receives the summary report and trial results and has a chance to review them internally, it plans to release the information to the public.
Algernon Pharmaceuticals' CEO Christopher J. Moreau commented, "While there has been an impressive advancement in the area of vaccine development and deployment, there still remains an urgent need to identify a therapeutic for the treatment of the most seriously affected COVID-19 patients...We sincerely hope that the trial results will show that Ifenprodil is reducing both the severity and duration of a COVID-19 infection."
The firm stated that it currently is not making claims of any kind as to Ifenprodil's ability to contain, cure or eliminate SARS-CoV-2, which is frequently referred to as the coronavirus or COVID-19.
The name of the Phase 2b/3 COVID-19 human trial is "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 explained that the Phase 2b part of the study that enrolled a total of 150 patients is complete and noted that should the Phase 2b data prove to be positive then it plans to quickly move forward directly into a Phase 3 trial. The company advised that the exact Phase 2b study results will dictate the size of the pool of patients needed in a Phase 3 trial to ensure statistical significance.
The company advised that patients enrolled in the Phase 2 part of the study were randomized and treated using an existing standard of care or standard of care plus Ifenprodil in either 60 mg or 120 mg doses spread across three equal daily doses for a period of two weeks.
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 explained that NMDA receptors can be found on tissues such as lung cells, T-cells and neutrophils.
The firm noted that 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 added that the release of cytokines can contribute greatly to highly problematic cytokine storm reactions that can result in loss of lung function and even death ultimately in patients infected with COVID-19.
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