Algernon Pharmaceuticals Announces Last Patient Treated in Phase 2 Study of IPF and Chronic Cough
Algernon Pharmaceuticals has announced the completion of patient treatment in its Phase 2 proof-of-concept study of NP-120 (Ifenprodil) for idiopathic pulmonary fibrosis (IPF) and chronic cough. Topline data is expected in July 2022. The trial enrolled 20 patients to assess Ifenprodil's safety and efficacy, focusing on lung function and cough reduction. The company aims to provide insights into the drug’s unique mechanism against current treatments, highlighting a pressing need for new options in managing IPF, which has a high mortality rate within 3-4 years.
- Completion of treatment in Phase 2 trial for Ifenprodil, nearing data release.
- Potential unique mechanism of action in treating IPF and chronic cough.
- Focus on critical endpoints such as lung function and cough reduction.
- No significant financial metrics or detailed efficacy results provided in the PR.
VANCOUVER, British Columbia, May 05, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that the last patient has completed the treatment period in its Phase 2 proof of concept study of NP-120 (“Ifenprodil”) for idiopathic pulmonary fibrosis (“IPF”) and chronic cough.
The Company is projecting that topline data will be available in July 2022.
“We are pleased to be coming closer to this value inflection point in our Phase 2 clinical trial for IPF and chronic cough, both debilitating conditions with limited treatment options,” said Christopher J. Moreau, CEO of Algernon. “We believe Ifenprodil has a unique mechanism of action when compared to the current standard of care for IPF and the drugs in development for chronic cough.”
Phase 2 Study Summary:
The purpose of this proof-of-concept Phase 2 human trial is to determine the safety and efficacy of Ifenprodil in patients with IPF and its associated cough.
In this open label, single-arm study, 20 patients were enrolled that had a diagnosis of IPF and a self-described moderate or worse cough (a score of >40mm on a cough visual analogue scale). Patients were treated with Ifenprodil (20 mg TID) for 12 weeks.
The primary endpoint of the IPF part of the study is the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. Lung function was measured by forced vital capacity (“FVC”).
The primary endpoint for the chronic cough portion of the study is a
However, based on data seen in recent IPF and chronic cough trials from other companies, Algernon will also perform a pre-specified subgroup analysis on patients with higher baseline cough counts. In addition, the Company will also measure the proportion of patients with a less than
In addition to safety and tolerability, the effect on serum biomarkers of fibrosis will also be reported including proC3, C3M, proC5, C5M, proC6, C6M and reC1M.
“Despite recent advances in the treatment of IPF, its prognosis remains dismal, with
About Ifenprodil
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.
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 intellectual property rights globally for Ifenprodil for the treatment of respiratory diseases.
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 regulators. 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
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