In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that the results it is observing from interim data in the Phase 2b part of its Phase 2b/3 clinical study of Ifenprodil for COVID-19 are trending in a positive direction.
Algernon Pharmaceuticals stated that a key endpoint in the study is defined as ventilation by day 15. The firm noted that it has noticed a trend toward fewer patients requiring mechanical ventilation in those patients who were administered the high dose Ifenprodil treatment, compared to patients in the control group. The consensus in the medical community presently is that mechanical ventilation is associated with poor prognosis and outcomes in COVID-19 patients and often results in greater risk of mortality and other serious complications.
The company advised that "although all patients had similar mean WHO and NEWS scores at day 15, there was a trend in the high dose group of Ifenprodil patients to reduce the NEWS score more quickly than control after treatment was initiated."
The firm noted that this suggests that patients may be recovering more quickly with Ifenprodil, which might help in reducing the number of days required for hospitalization. The company pointed out that even though the average number of days in the hospital is not one of the exact predetermined metrics included in the interim analysis, this data will be included in the final data set as some other firms have been successful at gaining emergency use authorization from the U.S. Food and Drug Administration based solely upon the ability to reduce the number of in-hospital days.
Algernon indicated that in the trial Ifenprodil has shown to be well tolerated and that no new serious safety concerns have been identified. The company said that the majority of adverse events reported were only mild to moderate in severity.
The firm commented that it had originally planned to use the data from the first 75 patients in the interim review, but it decided to increase the number to up to 123 patients for some of the parameters in the study since that data has become available. The company anticipates that the final Phase 2b data set will be available in Q1/21.
The company indicated that when the final data set is presented it will include additional key endpoints that were not analyzed in the interim data and said these other metrics will include items such as time to discharge from the hospital and time on mechanical ventilation.
The firm noted that the primary goals of the Phase 2b section of the trial is identify the appropriate endpoints for the Phase 3 portion of the study and to determine the number of patient participants necessary to insure that the results will be statistically significant.
The company's CEO Christopher J. Moreau remarked, "While we are very pleased that the interim data has provided us with some positive trending information, we still need to evaluate the full definitive results and statistics to be presented with the final data set...We will be especially interested to see the numbers on the overall time spent on ventilation and rate to ventilation to be reported in the final data set."
Algernon Pharmaceuticals commented that it is not making claims currently of any kind regarding the ability of Ifenprodil to contain, cure or eliminate SARS-CoV-2.
Algernon described NP-120 (Ifenprodil) as "a N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) that prevents glutamate signaling," and explained that NMDA receptors are found on many types of tissues including lung cells, T-cells, and neutrophils.
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