Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF), a clinical stage Canadian pharmaceutical development company, has provided an update on its chronic kidney disease (CKD) research program with NP-251 or Repirinast.
The company said in a pre-clinical animal model of kidney fibrosis, Repirinast reduced fibrosis by 50% with statistical significance, and showed an additive improvement when given in combination with Telmisartan, a blood pressure lowering medication considered to be a front line, standard of care treatment for CKD.
Algernon previously announced 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.
As part of the new CKD research program, Algernon said it will also investigate the use of Repirinast in acute interstitial nephritis, which causes inflammation of parts of the kidney.
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Algernon said Zhejiang Ausun Pharmaceutical Co, a China-based company it retained to manufacture its own supply of cGMP grade Repirinast, has now developed and optimized a new synthetic route to Repirinast.
The last major step on a full-scale engineering batch has been completed, it said, adding that the final material for toxicology studies and formulation development is expected to be delivered in late July 2022.
Ausun, which had developed and validated all analytical methods for testing, will conduct a bridging sub-acute toxicology study when the Repirinast cGMP synthesis is completed.
The study is expected to take 90 days to complete, following which Algernon plans to begin a small phase 1 study in the fourth quarter of this year to determine the bioavailability of the 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," Algernon CEO Christopher J Moreau said in a statement.
"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," he added.
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 focused on managing symptoms and complications that include high blood pressure, swelling, and anemia.
Growing at a compounded annual growth rate of 3.60% between 2016 and 2024, the global CKD drug market is expected to reach US$15.8 billion by the end of 2024.
Contact the author at jon.hopkins@proactiveinvestors.com