In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced that it has received a "No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial." The firm advised that it is preparing the same study protocol in parallel for submission to both the U.S. Food and Drug Administration and regulatory authorities in Australia.
The company's Chief Science Officer Dr. Mark Williams commented, "The study is an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) to determine if Ifenprodil can improve clinical symptoms of COVID-19 by reducing the number of COVID-19 diagnosed patients from progressing to mechanical ventilation with intubation and death."
Algernon Pharmaceuticals' CEO Christopher J. Moreau remarked, "We are very excited to have received clearance for our Phase 2b/3 study...We will begin to work immediately to get all aspects of the trial organized so that we can start as soon as possible including filing an IND for this same study with the U.S. FDA."
The firm stated that the trial will start off as a Phase 2b study of 100 patients and that after an interim analysis is completed on this first group of patients, the resulting data will determine the projected number patients required for Phase 3 to achieve statistical significance.
The company indicated that patients in the NP-120 (Ifenprodil) study will be randomized to receive either standard of care (SOC) or SOC and Ifenprodil 20 mg over a two-week period. The firm advised that the primary endpoint is to demonstrate an improvement in the WHO ordinal clinical scale. Additional secondary endpoints will be measured including mortality, blood oxygen levels, time in the ICU and time to mechanical ventilation.
The company said it is preparing to kick off the Phase 2 clinical trial soon in Canada and South Korea, but cautioned that "it is not making any express or implied claims that NP-120 (Ifenprodil) is an effective treatment for acute lung injury, the COVID-19 virus, or any other medical condition at this time."
The firm explained that "NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB) and that Ifenprodil prevents glutamate signaling." The company stated that "it believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively and the latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients."
Algernon Pharmaceuticals is a drug re-purposing firm based in Vancouver, which investigates safe, already approved drugs for new disease applications.
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