Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced in a news release that after an interim review, the external Data and Safety Monitoring Board approved the continuation of the biopharma's multinational Phase 2b/3 human study of NP-120, or Ifenprodil, as a COVID-19 treatment.
"Clinical studies are focused on the issues of safety and efficacy," Algernon CEO Christopher J. Moreau said in the release. "We are very confident of Ifenprodil's safety, and we look forward to discovering its efficacy in this very important COVID-19 trial."
Currently, the trial is in progress as a Phase 2b involving 150 patients. They are being randomized on a 1:1 basis to receive, for two weeks, either existing standard of care or standard of care plus Ifenprodil.
The latter group consists of two cohorts. One is receiving 60 milligrams (60 mg), taken in a 20 mg tablet three times a day. The other is receiving Ifenprodil 120 mg, taken as two 20 mg tablets three times a day.
"Over the testing period, 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 company stated.
If the results of the Phase 2b are positive, the study will automatically move into Phase 3. The number of participants needed for statistical significance will be determined at that time, based on the new data.
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