Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) revealed that it has awarded a contract to China’s Zhejiang Ausun Pharmaceutical Company Limited to begin the manufacturing of a cGMP supply of its repurposed drug candidate NP-251 (Repirinast) and has initiated a new chronic kidney disease (CKD) research program.
Algernon is a drug repurposing company that investigates safe, already approved drugs for new disease applications.
The Vancouver, British Columbia-based company said Repirinast was originally developed by Mitsubishi Tanabe Pharma. It was sold in Japan under the brand name Romet for the treatment of asthma for over 25 years. Repirinast was approved in Japan for patients with bronchial asthma in 1987 to prevent attacks when administered regularly. In 2013, Mitsubishi discontinued manufacturing and sales of the drug.
Repirinast is one of several repurposed drug candidates that were part of Algernon's acquisition of NASH Pharmaceuticals Inc on October 22, 2018.
Significantly, in a unilateral ureteral obstruction mouse model of kidney fibrosis conducted by NASH, Repirinast reduced fibrosis by 50%. It also showed a modest, but significant, synergistic improvement in combination with telmisartan, which is a blood pressure lowering drug and is considered a frontline standard of care treatment for CKD. As part of the new CKD research program, Algernon said it will also investigate the use of Repirinast in acute interstitial nephritis.
"Current treatment of CKD usually consists of measures to help control signs and symptoms, reduce complications, and slow progression of the disease, but there is no cure and new treatment options are needed," Algernon CEO Christopher J. Moreau said in a statement. "The pre-clinical data is showing that Repirinast may represent a promising new potential therapy and we look forward to advancing it as quickly as possible into human trials."
CKD is a condition in which the kidneys are damaged or cannot filter blood often because of fibrosis. As a result, excess fluid and waste from the blood remain in the body and cause other health problems. While there is no known cure, kidney disease complications can be controlled to make patients more comfortable.
Algernon cited figures showing that the global CKD drug market, which was pegged at US$11.5 billion in 2015, is expected to expand to US$15.8 billion by the end of 2024.
Clinical research plan
Algernon is in the early planning stages of its clinical research program and is considering the option of conducting its initial trial in Australia. Research conducted in Australia would be reimbursed under the Australian Scientific Research Tax Credit Program at a rate of 43.5%.
Algernon has retained its Asia Pacific CRO partner Novotech to conduct a feasibility study for the company's Repirinast CKD clinical research plan.
It is also planning to conduct trials in the US and will accordingly file a pre-Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).
Since there is no current Repirinast finished product to use as a comparator for Algernon's planned new cGMP supply, 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, said Algernon.
In addition, the company is planning to conduct a small Phase 1 study in the fourth quarter of 2022, to determine the bioavailability of its newly planned Repirinast finished product.
The CKD program’s lead consultant, Dr Chirag Parikh, is the Director, Division of Nephrology and Professor of Medicine at Johns Hopkins University. He carries out patient-oriented research programs investigating the translational and epidemiological aspects of acute kidney injury (AKI) and other kidney related disorders. Dr Parikh has written over 250 peer-reviewed papers, 50 book chapters and reviews.
In addition to Novotech, Algernon has also retained contract research organization Clinical Development Solutions to support the investigational brochure, study protocol and pre-IND and IND applications. It will also provide high-level oversight and management of all clinical trials, said the firm.
Algernon's patent applications for Repirinast embraces the treatment of CKD, as well as dosing and in combination with several cholesterol-lowering or antihypertensive drugs.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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