Algernon Pharmaceuticals Provides Update on its Planned Phase 1 Repirinast Chronic Kidney Disease Study
Algernon Pharmaceuticals Inc. (CSE: AGN, OTCQB: AGNPF) announced progress in its chronic kidney disease (CKD) research program using Repirinast, previously an asthma drug. In pre-clinical tests, Repirinast significantly reduced kidney fibrosis by 50%. The company is also exploring its use for acute interstitial nephritis. Manufacturing is underway, with a toxicology study planned post-synthesis, followed by a Phase 1 study set for Q4 2022. The global CKD drug market is projected to reach $15.8 billion by 2024, reflecting a substantial opportunity for Algernon's research endeavors.
- Repirinast reduced kidney fibrosis by 50% in pre-clinical studies.
- Research program aims to target unmet needs in CKD.
- Manufacturing of cGMP grade Repirinast is progressing well.
- Potential expansion of Repirinast's indication to acute interstitial nephritis.
- Completion of the toxicity studies and Phase 1 trials may encounter delays.
VANCOUVER, British Columbia, July 11, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a clinical stage Canadian pharmaceutical development company, is pleased to provide an update on its chronic kidney disease (“CKD”) research program with NP-251 (“Repirinast”).
In Q1 2022, the Company announced that it had initiated a new CKD research program to investigate Repirinast as part of its drug repurposing program. Repirinast was originally an asthma drug developed by Mitsubishi Tanabe Pharma, for the Japanese market.
In a pre-clinical animal model of kidney fibrosis, Repirinast reduced fibrosis by
The Company previously announced It had retained Zhejiang Ausun Pharmaceutical Co. of China (“Ausun”) to manufacture its own supply of cGMP grade Repirinast. Ausun has now developed and optimized a new synthetic route to Repirinast. The last major step on a full-scale engineering batch has been completed, and final material for toxicology studies and formulation development is expected to be delivered in late July 2022. Ausun has also developed and validated all analytical methods for testing.
The Company will conduct a bridging sub-acute toxicology study when the Repirinast cGMP synthesis is completed. The sub-acute toxicology study is expected to take approximately 90 days. Once completed, the Company plans to begin a small Phase 1 study in Q4, 2022, to determine the bioavailability of its Repirinast finished product.
“It’s important to note that while we wait for Phase 2 data from our proof-of-concept idiopathic pulmonary fibrosis and chronic cough study, Algernon’s business model is to have multiple research programs under development at the same time,” said Christopher J. Moreau CEO of Algernon. “Both stroke and CKD are serious global disease areas with unmet needs and the pre-clinical data showing the potential of DMT and Repirinast in treating these conditions, respectively, is very strong.”
Intellectual Property
Algernon’s patent applications for Repirinast include the treatment of CKD as well as dosing and in combination with several cholesterol-lowering and/or antihypertensive drugs.
About Chronic Kidney Disease (“CKD”)
CKD is a condition in which the kidneys are damaged or cannot filter blood as well as healthy kidneys, often because of fibrosis. As a result, excess fluid and waste from the blood remain in the body and may cause other health problems.
While there is no known cure, kidney disease complications can be controlled to make patients more comfortable. Treatments are focussed on managing symptoms and complications that include high blood pressure, swelling, and anemia.
The global market for CKD drugs continues to grow at a significant pace, driven by the increasing number of CKD patients and the growing need for novel treatments to improve patients’ quality of life. The global CKD drug market stood at US
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. 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.
FAQ
What is the purpose of Algernon Pharmaceuticals' CKD research program?
What were the results of the pre-clinical studies for Repirinast?
What are the next steps for the Repirinast research program?
How does the CKD drug market opportunity impact AGNPF?
