Algernon Pharmaceuticals Provides Update on Timing of Topline Results for Phase 2b/3 COVID-19 Trial of Ifenprodil
Algernon Pharmaceuticals expects to report topline results from the Phase 2b part of its Phase 2b/3 COVID-19 trial of Ifenprodil in the last week of March 2021. This multinational study aims to evaluate Ifenprodil's safety and efficacy in hospitalized COVID-19 patients. The independent statisticians will review the data before public release. CEO Christopher J. Moreau emphasizes an urgent need for effective COVID-19 therapies. The trial's positive outcomes could lead to a Phase 3 trial with a larger patient cohort, aiding in the fight against severe COVID-19.
- Ifenprodil trial expects topline results by end of March 2021.
- The Phase 2b part of the trial saw completion with potential for positive data.
- Success in Phase 2b may accelerate transition into Phase 3 trial.
- Trial results are pending; uncertainty remains until data is analyzed.
- No claims can be made regarding Ifenprodil's efficacy against COVID-19.
VANCOUVER, British Columbia, March 11, 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 expects to report its topline results for the Phase 2b part of its Phase 2b/3 COVID-19 trial of Ifenprodil, in the last week of March 2021.
During the data review period, neither the Company nor any party other than the independent statisticians will have access to the data. Once the data has been analyzed, the Company will receive the trial results and after a brief internal review, the data will be released to the public.
“While there has been an impressive advancement in the area of vaccine development and deployment, there still remains an urgent need to identify a therapeutic for the treatment of the most seriously affected COVID-19 patients,” said Christopher J. Moreau, CEO of Algernon. “We sincerely hope that the trial results will show that Ifenprodil is reducing both the severity and duration of a COVID-19 infection.”
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.
Phase 2b/3 Study Summary:
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."
The trial began as a Phase 2b study of an aggregate of 150 patients, which has now been completed. With positive data from the Phase 2b part of the study, the clinical trial can 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 were randomized in a 1:1:1 manner and were treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (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.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.
The Company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.
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.
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