Algernon Pharmaceuticals Inc. (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 50% with statistical significance. It also showed an additive improvement when given in combination with Telmisartan, the latter of which is a blood pressure lowering medication and is considered a front line, standard of care treatment for CKD. As part of the new CKD research program, the Company will also investigate the use of Repirinast in acute interstitial nephritis, which causes inflammation of parts of the kidney.
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,” “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.”
Christopher J. Moreau CEO of Algernon
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 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$11.5 Billion in 2015. Growing at a CAGR of 3.60% between 2016 and 2024, the market’s opportunity is expected to reach US$15.8 Billion by the end of 2024.
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.