Algernon Announces 75% Enrollment in Multinational Phase 2b/3 Human Study of Ifenprodil for Treatment of COVID-19
Algernon Pharmaceuticals Inc. (OTCQB: AGNPF) has successfully enrolled 75% of its target for a Phase 2b/3 trial of NP-120 (Ifenprodil) aimed at treating COVID-19, with 113 patients expected for the study. Conducted across the U.S., Australia, Philippines, and Romania, the trial has received approval from the Data and Safety Monitoring Board to proceed. Completion is projected for November 2020, with results anticipated by the end of Q4. The trial aims to assess Ifenprodil's impact alongside standard care on various health metrics of hospitalized patients.
- 75% of patient enrollment target reached for Phase 2b/3 trial.
- Study approved to continue by Data and Safety Monitoring Board.
- Projected completion of the trial set for November 2020.
- No express claims made regarding Ifenprodil's efficacy against COVID-19.
VANCOUVER, British Columbia, Oct. 02, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has now enrolled
The multinational human trial is being conducted in the U.S., Australia, the Philippines and Romania.
The Company recently announced that the external Data and Safety Monitoring Board (DSMB) had unanimously approved the continuation of its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The DSMB is a committee of clinical research experts, such as physicians and statisticians, and patient advocates who monitor the progress of a clinical trial and review safety and effectiveness data while the trial is ongoing.
The Company has projected that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020.
The Company is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
Phase 2b/3 Study Protocol 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 has begun as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will 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 are being randomized in a one-to-one manner and will either be 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.
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.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils.
The Company believes Ifenprodil 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 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.
Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com
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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 Phase 2b/3 trial for NP-120 (Ifenprodil)?
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What are the expected outcomes being measured in the NP-120 trial?
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What is the significance of reaching 75% enrollment in the NP-120 trial?
