In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that "the external Data and Safety Monitoring Board (DSMB) has completed its latest review of the Phase 2b part of the company's Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19 and has provided approval for the company to continue on with the Phase 3 part of the study."
Algernon Pharmaceuticals explained that the DSMB is tasked with monitoring the activities, processes and progress of the firm's clinical study and reviewing ongoing safety and effectiveness data throughout the course of the trial. The firm noted that the DSMB committee is composed of clinical research experts, patient advocates, physicians and statisticians.
Algernon Pharmaceuticals' CEO Christopher J. Moreau commented, "While we await final data from the Phase 2b part of our Ifenprodil COVID-19 study, it is critical for us to know that from a safety perspective, we are now clear to move into the Phase 3 part of the study."
The company 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.
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 advised 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 firm noted that it has been widely reported that the release of cytokines frequently contributes to the incidences of highly problematic cytokine storm that can cause loss of lung function and eventually death in patients infected with COVID-19.
The company stated that it has filed new global intellectual property rights for NP-120 (Ifenprodil) to be used in the respiratory disease treatment and mentioned that is presently concentrating on developing both injectable and slow release formulations.
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