Algernon Pharmaceuticals Files End of Phase 2 Meeting Request with U.S. FDA for its COVID-19 Trial of Ifenprodil
VANCOUVER, British Columbia, April 26, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, announces that it has filed an end of Phase 2 meeting request (EOP2) with the U.S. Food and Drug Administration (“FDA”), based on the completion of the Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).
The purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design, to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan, including protocols and endpoints for adequacy, and to identify information necessary to support a marketing application.
The FDA guidelines show that the Company can expect a response within 70 days, although with the topic of the meeting being a COVID-19 clinical trial, the response may be expedited.
The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
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