Algernon Pharmaceuticals Announces it Will Not Advance Ifenprodil into Phase 3 Trial for COVID-19
Algernon Pharmaceuticals Inc. (CSE: AGN, OTCQB: AGNPF) announced it will not advance Ifenprodil into a Phase 3 clinical study for COVID-19. This decision follows findings from a Phase 2b trial, the impact of widespread vaccinations, and insights from the FDA. Despite this setback, Algernon remains committed to other programs, including ongoing trials for Ifenprodil targeting idiopathic pulmonary fibrosis and chronic cough, alongside upcoming studies for DMT in stroke and pancreatic cancer. The company emphasizes its support for research during the pandemic and continues its drug re-purposing efforts.
- Continued progress in other clinical trials, including a Phase 2 trial of Ifenprodil for idiopathic pulmonary fibrosis and chronic cough.
- Plans for a Phase 1 trial of DMT targeting stroke by the end of October 2021.
- Upcoming Phase 1 trial for pancreatic cancer in Q1 2022.
- Decision not to advance Ifenprodil into a Phase 3 clinical study for COVID-19.
- Phase 2b study findings were not favorable for advancing Ifenprodil.
VANCOUVER, British Columbia, July 06, 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 will not be advancing Ifenprodil into a Phase 3 clinical study for COVID-19.
The Company’s decision was based on several factors including the overall findings of the Phase 2b COVID-19 study final data set, the global rate of vaccinations to date, other COVID-19 drug treatment programs under development, and the projected trial size, costs and timelines needed to successfully complete a Phase 3 trial. Feedback recently received from the U.S. Food and Drug Administration regarding the Company’s end of Phase 2 meeting request was also informative.
When Algernon made the decision to investigate Ifenprodil as a possible COVID-19 treatment, the world was at the very beginning of the worst pandemic seen since the 1918 Spanish Flu. As a result, treatments for COVID-19 were desperately needed and since novel vaccine research and trials have historically taken a minimum of three to five years to complete, Algernon committed to researching Ifenprodil as a possible therapeutic option quickly and efficiently using its unique drug re-purposing program.
However, due to an extraordinary effort by scientists, governments, and many companies throughout the world, people have now gained access to multiple effective vaccines for COVID-19 in less than a year from the initial research start date, reducing hospitalizations and improving patient outcomes. This rapid progress was unprecedented and has now allowed billions to become vaccinated and has resulted in the re-opening of countries and economies at an ever-increasing rate.
“As a small drug development company, we always need to consider the cost benefit analysis of all of our research programs and be responsive to the realities of the marketplace as they continue to evolve,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “As a Canadian company, we tried to do our part to help in the fight against a global pandemic. Even though we are not moving Ifenprodil forward for COVID-19, I am very proud and thankful for all the work the entire Algernon team has accomplished and especially for the support of our many investors and stakeholders around the world.”
Algernon’s decision will not affect any of its other research programs including investigating Ifenprodil for other disease indications. Algernon has several clinical stage programs currently in progress including a Phase 2 trial of Ifenprodil for idiopathic pulmonary fibrosis and chronic cough. The Company is also planning a Phase 1 clinical trial for the psychedelic drug DMT and stroke by the end of October of this year, as well as a Phase 1 trial for pancreatic cancer in Q1, 2022.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates well-tolerated, 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.
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.
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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