Pharma Focus Asia

Algernon Pharmaceuticals Begins Manufacturing of Repirinast and Launches New Chronic Kidney Disease Research Program

Thursday, February 24, 2022

Algernon Pharmaceuticals Inc.  a clinical stage pharmaceutical development company is pleased to announce that it has awarded a contract to Zhejiang Ausun Pharmaceutical CO, LTD of China 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.

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.

Repirinast was approved in Japan for patients with bronchial asthma in 1987, to prevent attacks when administered regularly. A pediatric formulation was also approved in 1990. Unlike most allergy medications, Repirinast does not have a direct antihistaminic effect. The drug acts on mast cells and inhibits the release of chemical mediators by IgE-related antigen antibody interactions.

Repirinast is one of several repurposed drug candidates that were part of Algernon’s acquisition of NASH Pharmaceuticals Inc. (“NASH”) on October 22, 2018.

Repirinast, in a unilateral ureteral obstruction (UUO) mouse model of kidney fibrosis conducted by NASH, reduced fibrosis by 50% with statistical significance. It also showed a modest, but significant, synergistic improvement in combination with telmisartan, 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.

“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,” said Christopher J. Moreau, CEO of Algernon. “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.”

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