Algernon Pharmaceuticals Announces Lead Chronic Kidney Disease Drug Repirinast Reduced Fibrosis by 56% in a Preclinical NASH Study

Rhea-AI Summary

Algernon Pharmaceuticals has announced promising results from a preclinical study of its lead compound, NP-251 (Repirinast), which demonstrated a significant 56% reduction in fibrosis related to chronic kidney disease (CKD) and non-alcoholic steatohepatitis (NASH) in animal models. The study showed statistical significance in the results, with strong implications for Repirinast’s potential as an anti-fibrotic treatment across various diseases. The company plans to advance Repirinast into a Phase 1 clinical trial, supported by a well-established safety history in the Japanese market.

Positive

• 56% reduction in fibrosis in preclinical study for CKD and NASH with statistical significance (p<0.0001).
• Repirinast has demonstrated anti-fibrotic capabilities in multiple organs in separate studies.
• Plans to move Repirinast into Phase 1 clinical trials, indicating progress in drug development.

Negative

• None.

VANCOUVER, British Columbia, April 26, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that its lead chronic kidney disease (“CKD”) drug NP-251 (“Repirinast”), reduced fibrosis by 56% with statistical significance, in a preclinical study investigating non-alcoholic steatohepatitis (“NASH”) in the STAM™ mouse model from SMC Laboratories (Japan).

Repirinast was one of multiple drugs that Algernon screened in a NASH preclinical animal study where liver tissue samples from the Repirinast treatment group underwent a pathology review using sirius red staining. The tissue analysis showed that when compared to the negative control group, Repirinast (60mg/kg QD) reduced fibrosis by 56% (p<0.0001).

The Company earlier reported, using the naming protocol NP-251, that Repirinast (30 mg/kg, TID) also reduced fibrosis by 51% vs. untreated controls (p=0.021) in its preclinical animal study of idiopathic pulmonary fibrosis (“IPF”). In the same study, Ifenprodil (4 mg/kg, TID) showed a 56% reduction in fibrosis vs. untreated controls (p=0.015).

Fibrotic disease is a major health problem worldwide. As the common pathological pathway to organ injury and failure, fibrosis usually represents an unsatisfactory prognosis. It is a major cause of death globally and causes substantial medical and economic burdens.¹

“When you include the CKD data, Repirinast has shown in three separate preclinical studies, that it has reduced fibrosis in three major fibrotic diseases involving three separate major human organs, all with statistical significance,” said Christopher J. Moreau, CEO of Algernon. “This data suggests that Repirinast has the potential to be an anti-fibrotic compound in multiple indications and so we look forward to advancing it into the planned Phase 1 study.”

About Repirinast

Repirinast was developed by Mitsubishi Tanabe Pharma and was sold and marketed in Japan under the brand name Romet™ for the treatment of asthma. Romet™ was marketed for over 25 years in Japan and has a well-established safety history. The drug acts on mast cells and inhibits the release of chemical mediators by IgE-related antigen antibody interactions.

Intellectual Property

Algernon has filed intellectual property rights globally for Repirinast for the treatment of CKD including dosing and combination with several cholesterol-lowering or antihypertensive drugs. The Company has also filed intellectual property rights globally for Repirinast for the treatment of IPF and NASH.

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.

(1) https://www.nature.com/articles/s41420-020-00316-9

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

What were the results of the Algernon Pharmaceuticals NP-251 (Repirinast) study?

The study revealed a 56% reduction in fibrosis related to chronic kidney disease (CKD) and non-alcoholic steatohepatitis (NASH) in preclinical models, with statistical significance.

What does the statistical significance of the NP-251 study imply?

The statistical significance (p<0.0001) implies that the results are unlikely due to chance, strengthening the case for Repirinast's potential in treating fibrotic diseases.

What are the next steps for Algernon Pharmaceuticals regarding NP-251?

Algernon Pharmaceuticals plans to advance NP-251 (Repirinast) into a Phase 1 clinical trial to explore its efficacy in humans.

What was Repirinast previously used for before being studied by Algernon Pharmaceuticals?

Repirinast was developed by Mitsubishi Tanabe Pharma and was marketed in Japan under the brand name Romet™ for the treatment of asthma.

What is the significance of Algernon Pharmaceuticals' intellectual property filing for Repirinast?

Algernon has filed intellectual property rights globally for Repirinast, which protects the compound's use in treating CKD, IPF, and NASH, enhancing its market potential.