Algernon Pharmaceuticals Inc (CSE:AGN), (OTCQB:AGNPF) (FRA:AGW) announced Friday that the Data and Safety Monitoring Board (DSMB) has once again unanimously approved the continuation of the company’s multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19.
The DSMB is a committee of clinical research experts, including physicians, statisticians, and patient advocates, who are monitoring the progress of the company’s clinical trial, and are reviewing safety and effectiveness data while the trial is ongoing. The board’s decision came after a second meeting and review.
“Clinical studies are focussed on the issues of safety and efficacy,” said CEO Christopher Moreau in a statement. “We are very confident of Ifenprodil’s safety and we look forward to discovering its efficacy in this very important COVID-19 trial.”
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The company’s multinational Phase 2b/3 human trial for COVID-19 is entitled, "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 said the trial is currently underway as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.
Patients are being randomized in a one-to-one manner and are either being treated using an existing standard of care or standard of care plus Ifenprodil 60 milligrams (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.
Over the testing period, the company said doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care, and time to mechanical ventilation.
The Vancouver-based company is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure, or contain COVID-19 (SARS-2 coronavirus) at this time.
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