VANCOUVER, British Columbia, Jan. 06, 2025 (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 it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for patent application 17/255,364 for its lead chronic kidney disease (CKD) program drug NP-251 (Repirinast).

The invention claims the use of Repirinast, either alone or in combination with telmisartan, for the treatment or prophylaxis of renal fibrosis or kidney disease. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The Company has been issued corresponding patents in Japan and China, with applications pending in Europe and Canada.

The Chronic Kidney Disease Market size is estimated at USD 84.85 billion in 2025, and is expected to reach USD 109.95 billion by 2030, at a CAGR of 5.32% during the forecast period (2025-2030).¹

Repirinast is the Company’s lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51% with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction (UUO) mouse model.

Algernon’s intellectual property strategy for its repurposed drug program includes protecting its compounds by filing patent applications including method of use, dosing and formulations, and for new composition of matter patents based on novel salt forms.

“Algernon’s intellectual property strategy for our innovative drug repurposing programs continues to be very successful,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “It is increasingly more difficult to confirm novelty and receive a method of use patent with the advent of AI being used as a drug discovery tool. It is an important achievement and provides substantial protection for Repirinast and its use as a treatment for kidney disease.”

Preclinical Data

Data from the UUO study demonstrated that clinically relevant doses resulted in statistically significant improvements in the reduction in fibrosis as measured by Sirius Red staining over untreated controls:

• Telmisartan (3 mg/kg), a positive control, reduced fibrosis by 32.6% (p<0.001)
• Cenicriviroc (40 mg/kg) a CCR2/5 chemokine receptor antagonist with reported anti-fibrotic activity, reduced fibrosis by 31.9% (p=0.00032).
• Repirinast (90 mg/kg) reduced fibrosis by 50.6% (p<0.000001).
• Repirinast (30 mg/kg) reduced fibrosis by 20.8% (p>0.05).
• The combination of Repirinast (30 mg/kg) and telmisartan (3 mg/kg) reduced fibrosis by 54.2% (p<0.000001). In addition, the mass of the fibrotic kidney was lower than the negative control (p<0.001).

About NP-251 (Repirinast)

Repirinast was originally developed by Mitsubishi Tanabe Pharma (“Mitsubishi”) 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. Mitsubishi discontinued manufacturing and sales of the drug in 2013. Accordingly, Algernon has retained Zhejiang Ausun Pharmaceutical in Zhejiang, China to manufacture a cGMP Repirinast supply.

Mast cells are recruited to sites of cellular damage, and degranulation of mast cells leads to release of a myriad of proinflammatory chemical mediators which lead to tissue damage in a self-propagating cascade. NP-251 binds to receptors on mast cells and prevents their degranulation, which the Company believes could help prevent fibrosis in multiple organ classes including the kidneys.

About Algernon Pharmaceuticals  

Algernon Pharmaceuticals is a Canadian clinical stage drug development company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals is also the parent company of a private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of DMT for stroke and traumatic brain injury.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

[email protected]
[email protected]
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.

¹ https://www.mordorintelligence.com/industry-reports/chronic-kidney-disease-market

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