In a news release, clinical stage pharmaceutical development company Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) presented some additional details clarifying the interim data reported for the Phase 2b portion of the firm's Phase 2b/3 clinical study of Ifenprodil for COVID-19.
Algernon Pharmaceuticals stated that it initially structured its Phase 2b/3 COVID-19 clinical trial protocol according to World Health Organization (WHO) guidelines under the WHO's master protocol version 2.0 dated Feb. 24, 2020. The company pointed out that these rules allow for a stated secondary endpoint to be changed to a primary endpoint going forward in the Phase 3 portion of a clinical trial.
Algeron noted that the goal of the Phase 2b part of its trial is to outline and investigate multiple endpoints and select those that display the highest efficacy. The firm said that this concept was anticipated and is incorporated into the clinical trial guidelines formulated by the WHO.
The company advised that after it had finalized its investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA), the FDA updated and changed its guidance pertaining to COVID-19 clinical trials. The firm mentioned that the FDA recommended "a preference for a respiratory failure-based endpoint as an alternative to the WHO score as the primary efficacy endpoint for the Phase 3 portion of the trial."
Algeron explained that clinical trials can be complex once undertaken and certain endpoints may validate efficacy while others may not. The company gave an example from its own Phase 2b study indicating that by day 15, there was a trend toward fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm versus patients grouped in the trial's untreated control arm even though all of the study's subjects had similar mean WHO and NEWS scores.
The company listed that by design its Phase 2b/3 trial encompasses many of the FDA's accepted COVID-19 trial endpoints. The firm listed that there six specific potential primary endpoints in its Phase 2b/3 trial including respiratory failure (which includes need for mechanical ventilation), need for intensive care, need for hospitalization, objective measure of sustained improvement such as oxygenation, ordinal measures of clinical improvement such as WHO and NEWS scores and lastly mortality.
The company advised that prior to the commencement of the study it has always been its intention to consult with the FDA on a possible path towards Emergency Use Authorization (EUA) after the completion of the Phase 2b final data set.
The firm's CEO Christopher J. Moreau commented, "The company believes that the interim data represents a very positive step in the investigation of Ifenprodil as a potential therapeutic treatment for COVID-19...We were very pleased to see positive trending data with a ventilation related endpoint that is favored by the FDA for COVID-19 trials. Further, Algernon has only provided interim data on three endpoints from day 15 of its 30-day Phase 2b/3 Ifenprodil COVID-19 study, with the majority of the data still to be reported."
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. The company added that at this time it is not making any assertions or claims of any kind regarding the ability of Ifenprodil to contain, cure or eliminate SARS-CoV-2.
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