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Algernon Pharmaceuticals Inc. (AGN.CN)

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0.1550-0.0100 (-6.06%)
At close: 3:57PM EDT
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Avg. Volume582,176
Market Cap24.136M
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News
  • Algernon Pharmaceuticals Announces 50% Enrollment of its Ifenprodil IPF and Chronic Cough Phase 2 Human Study
    GlobeNewswire

    Algernon Pharmaceuticals Announces 50% Enrollment of its Ifenprodil IPF and Chronic Cough Phase 2 Human Study

    VANCOUVER, British Columbia, May 11, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCB: BTHCF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has reached 50% of its enrollment target for its Phase 2 idiopathic pulmonary fibrosis (IPF) and chronic cough clinical study of its re-purposed drug NP-120 (Ifenprodil). The purpose of this 20 patient proof-of-concept Phase 2 human trial is to determine the efficacy of Ifenprodil in the preservation of lung function in IPF patients (including biomarkers of fibrosis) and its associated chronic cough. There are six sites in total participating in the study with four located in Australia and two in New Zealand. Ifenprodil has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of IPF and significantly reduced cough frequency and delayed onset in a guinea pig acute cough model. IPF Animal Study Summary Ifenprodil reduced fibrosis in a well-established in vivo animal model. Data from this study showed a 56% reduction in fibrosis vs. untreated controls (p=0.015) in a 21-day bleomycin mouse model (treatment began on Day 7). Chronic Cough Animal Study Summary Ifenprodil (1.5 mg/kg) showed a reduction of 42% in mean cough frequency vs. untreated control (p<0.01) in a well-accepted acute cough in-vivo animal study. Ifenprodil showed a statistically significant delay (59.8 seconds) in the onset of the first cough when compared to control, which was 34.2 seconds (p<0.05). About IPF Idiopathic pulmonary fibrosis, an orphan disease, is a type of chronic lung condition characterized by a progressive and irreversible decline in lung function and scarring (fibrosis) of the lungs. There is no cure for IPF and there are currently no procedures or medications that can remove the scarring from the lungs. According to research and consulting firm GlobalData’s latest report, the idiopathic pulmonary fibrosis (IPF) market will rise substantially from just over $900 million in 2015 to $3.2 billion by 2025, representing a projected compound annual growth rate (CAGR) of 13.6%. About Chronic Cough A chronic (persistent) cough is a cough lasting eight weeks or longer in adults, or four weeks in children. Chronic cough can interrupt sleep, cause exhaustion and in severe cases can cause serious vomiting, light-headedness and rib fractures. According to a research report from IndustryARC™ the chronic cough remedies market size was estimated to be $11.4 billion in 2018 and projected to grow at a CAGR of 6.64% between 2019-2024. Despite the need for a serious and effective medicinal treatment, pleasant tasting oral syrups are today among the best treatments offered by medical science. Some traditional chronic cough remedies even include drinking honey, bromelain and bacterial microbes. Further, some new generation cough remedies include corticosteroids, bronchodilators and antibiotics. 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. MoreauCEOAlgernon Pharmaceuticals Inc.604.398.4175 ext 701info@algernonpharmaceuticals.cominvestors@algernonpharmaceuticals.comwww.algernonpharmaceuticals.com. The CSE does not accept 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.

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

    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. CONTACT INFORMATION Christopher J. MoreauCEOAlgernon Pharmaceuticals Inc.604.398.4175 ext 701info@algernonpharmaceuticals.cominvestors@algernonpharmaceuticals.comwww.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.

  • Algernon Pharmaceuticals to File End-of-Phase 2 Meeting Request with U.S. FDA for Possible Ifenprodil Phase 3 COVID-19 Trial
    GlobeNewswire

    Algernon Pharmaceuticals to File End-of-Phase 2 Meeting Request with U.S. FDA for Possible Ifenprodil Phase 3 COVID-19 Trial

    VANCOUVER, British Columbia, April 08, 2021 (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 plans to formalize discussions with the U.S. Food and Drug Administration (“FDA”) by filing an End-of-Phase 2 meeting request (EOP2) based on the completion of the Phase 2b part of its Phase 2b/3 COVID-19 trial (the “Study”) of NP-120 (Ifenprodil). Algernon has now completed its initial review of the full data set from the Study and will be seeking guidance from the FDA on moving forward with a potential Phase 3 study. 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. As part of the EOP2 meeting request, the Company is preparing a briefing package that includes a summary of Study data and a protocol synopsis for a potential Phase 3 trial. The EOP2 meeting is an essential part of the process to help guide the Company and determine the next steps forward. The EOP2 meeting will focus on the data from three key endpoints from the Study including all-cause mortality, oxygenation (SpO2) and time in ICU, from the 20mg Ifenprodil treatment arm. The Company has been reviewing the data from the 40mg Ifenprodil treatment arm of the Study. While the full data set review confirmed no significant changes were observed compared to the untreated arm of the Study, the data showed a negative dose effect trend with some clinical outcomes. As a complex receptor, NMDA’s relationship with drugs that stimulate or inhibit it is not completely understood. In some cases of being inhibited or antagonized, the receptor, instead of shutting down, appears to protest over-inhibition, possibly leading to adverse responses in patients. This has been identified in studies of Memantine and Ketamine, also NMDA receptor antagonists. This may represent a class effect observed at doses higher than those at which a more customary dose-response relationship is shown, and as such, may inform observations on the 40mg dose data. There was very little historical data to guide dosing for this Study of Ifenprodil in COVID-19 patients, and the Company chose to include a high dose 40mg treatment arm in the Study, in view of Ifenprodil’s considerable safety record. “When we consider the totality of the Study’s data set, we are very confident that the next appropriate step is a formal EOP2 meeting with the FDA in order to discuss the results and explore the potential of a Phase 3 trial,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “We look forward to feedback from the FDA so that we can determine our next steps.” 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 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. CONTACT INFORMATION Christopher J. MoreauCEOAlgernon Pharmaceuticals Inc.604.398.4175 ext 701info@algernonpharmaceuticals.cominvestors@algernonpharmaceuticals.comwww.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.