Algernon Pharmaceuticals Files End of Phase 2 Meeting Request with U.S. FDA for its COVID-19 Trial of Ifenprodil

Rhea-AI Summary

Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has filed an end of Phase 2 meeting request with the FDA following the completion of its Phase 2b clinical trial for NP-120 (Ifenprodil) in COVID-19. This meeting aims to discuss clinical trial design and assess the transition to Phase 3 with expedited responses expected due to the pandemic context. The company clarifies it does not claim Ifenprodil can treat or prevent COVID-19. Algernon focuses on repurposing existing drugs for new therapeutic applications.

Positive

• Filed end of Phase 2 meeting request with FDA.
• Completion of Phase 2b trial for NP-120 (Ifenprodil) in COVID-19.
• Expedited response expected from FDA due to pandemic.

Negative

• None.

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.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

FAQ

What is the purpose of Algernon's end of Phase 2 meeting request with the FDA regarding AGNPF?

The meeting aims to discuss trial design, evaluate safety for Phase 3, and assess the adequacy of protocols and endpoints.

What did Algernon Pharmaceuticals achieve with the completion of its Phase 2b trial?

The completion of the Phase 2b trial for NP-120 (Ifenprodil) allows Algernon to file for an EOP2 meeting with the FDA.

When can Algernon Pharmaceuticals expect a response from the FDA after filing the EOP2 meeting request?

The company can expect a response from the FDA within 70 days, with potential for expedited review due to its COVID-19 focus.

What therapeutic application is Algernon Pharmaceuticals exploring with Ifenprodil?

Algernon is investigating Ifenprodil for potential use in treating COVID-19, although no claims are made regarding its efficacy.