Wholly owned subsidiary of Ascletis Pharma Inc., Gannex Pharma Co., Ltd., has reportedly obtained the IND approval of the U.S. Food and Drug Administration for its Non-Alcoholic Steatohepatitis (NASH) drug candidate ASC42.
According to Handen He, the Chief Scientific Officer of Ascletis, the organization is thrilled to witness that FDA has cleared ASC4 IND application for NASH, which is becoming increasingly prevalent with no presently approved therapies, adding that this represents a significant milestone that permits the company to begin with its clinical trials. The company will be consistently dedicated to patient-centric innovation and the development of new medicines for addressing the unmet requirements in NASH treatment, added He.
NASH is the progressive representation of non-alcoholic fatty liver disease (NAFLD), which has been characterized by the accumulation of fibrosis, inflammation, and fat in the liver. The disease is a critical cause of liver disease at the global level and the primary cause of liver transplants for people under the age of 50 in the United States.
Gannex has two more drug candidates at the clinical stage in its NASH pipeline, ASC41 and ASC40, state reports. The company’s oral fatty acid synthase inhibitor, ASC40 has been depicted to considerably lower liver fat with a responder rate of 61 per cent in the 50 mg group in the second phase of clinical trial. ASC41 is a liver-targeted prodrug with its active moiety being selective for THR-β, state sources. The company’s ASC42 is likely to be utilized in isolation or in combination with ASC41 or ASC40, state reports.
For the uninitiated, Ascletis is an innovative research and development driven biotechnology major. Listed on the Hong Kong Stock Exchange, the company is dedicated to the commercialization and development of HIV/AIDS, viral hepatitis, and NASH for unmet medical requirements in China and at the global level.