Vancouver-based Algernon Pharmaceuticals has granted a contract to Chinese Zhejiang Ausun Pharmaceutical for mass production of Repirinast along the lines of Current Good Manufacturing Practices (cGMP). Algernon has also launched a research program on Chronic Kidney Disease (CKD).
Repirinast is the repurposed form of Romet™, initially developed by the Mitsubishi Tanabe Pharma for patients with asthma. Romet™ was manufactured and sold in Japan for over 20 years before being discontinued in 2013.
In 1987, Repirinast was cleared for marketing among patients with bronchial asthma. The drug prevents attacks when used routinely, even in the pediatric population. The drug does not mediate its effect on histamine. It acts on mast cells and stops the secretion of cytokines by IgE-related antigen-antibody interactions.
Algernon acquired NASH Pharmaceuticals on October 22, 2018, and repurposed Repirinast.
Repirinast has been shown to reduce fibrosis by 50% in cases of unilateral ureteral obstruction in mice. It has shown promising results when combined with telmisartan in lowering blood pressure. This combination is thought to be the first-line treatment for Chronic Kidney Disease, and Algernon will explore the efficacy of Repirinast in acute interstitial nephritis as well.
“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.”
Chronic Kidney Disease
CKD is a human condition in which kidney function is compromised, and the kidneys face difficulty filtering blood as compared to normal functioning kidneys.
CKD is not curable, but patients can be made more comfortable by preventing complications. Treatment is directed towards the management of hypertension, edema, and anemia
The worldwide market for CKD drugs keeps developing at a critical speed, driven by the expanding number of CKD patients and the increasing requirement for novel medicines to work as per patients’ satisfaction. The worldwide CKD drug market remained at US$11.5 Billion in 2015. Developing at a CAGR of 3.60% from 2016 to 2024, the market’s chance is expected to arrive at US$15.8 Billion before 2024 ends.
Manufacturing
Repirinast was manufactured only by Mitsubishi before but has since been discontinued. Algernon Pharmaceuticals has shown confidence in China-based Zhejiang Ausun Pharmaceutical to meet the global demand through cGMP manufacturing.
Algernon is in the initial arrangement phases of its research project and is thinking about the choice of conducting its first trial in Australia, which would be repaid by the Australian Scientific Research Tax Credit Program at a pace of 43.5%.
The Company has held its Asia Pacific CRO accomplice Novotech to direct a practicality study for Algernon’s Repirinast CKD clinical study plan.
The Company is likewise intending to lead trials in the U.S. and will, as needs be, document a pre-IND application with the U.S. Food and Drug organization.
Moreover, Algernon is intending to lead a small Phase 1 study in the 4th quarter of 2022, to decide the bioavailability of its recently developed Repirinast completed item.
