In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced it received ethics approval from a central institutional review board for U.S. study sites to conduct its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) as a treatment for COVID-19 at five in-country sites.
Based on feedback from the U.S. Food and Drug Administration feedback, the Vancouver, British Columbia-based biopharma added another arm to the trial design. This cohort will consist of 50 additional patients who will receive a higher Ifenprodil dose.
Now, patients will be randomized on a 1:1:1 basis to receive one of three treatment regimens. One is standard of care. Another is standard of care plus Ifenprodil 60 milligrams (60 mg), administered in a 20 mg tablet three times a day. The third is standard of care plus Ifenprodil 120 mg, given in two 20 mg tablets three times daily.
The primary endpoint will be the change in patients' clinical score using the World Health Organization's ordinal scale. Secondary endpoints will include improvement in mortality, blood oxygen levels, intensive care stay duration and time to mechanical ventilation.
Should initial data from Phase 2b be positive, the study will immediately move into Phase 3.
The U.S. and Canada are now on board for the trial, and Algernon is working to get approval from Australia, Romania and the Philippines as well to include, in the study, sites in their country.
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