Ganley Pharmaceuticals has submitted an application for a U.S. clinical trial of NASH's new drug ASC42 (FXR astride).

ASC42 is an in-house development of The Vaniol X-recital (FXR) astigation agent developed in-house by Ganley Pharmaceuticals.
two NASH animal models, ASC42 showed significant improvements in liver fatty degeneration, inflammation and fibrosis.
also has two clinically-staged drug candidates in its NASH pipeline, ASC40 and ASC41, respectively.
ASC42 can be used alone or in union with ASC40 or ASC41.
ASC40 is an oral fatty acid synthase (FASN) inhibitor.
In this randomized, placebo-controlled Phase II clinical study (FASCINATE-1), clinical researchers assessed the safety and effectiveity of ASC40 (TVB-2640) in 99 U.S. NASH patients, given once a day for 12 weeks.
clinical data showed that ASC40 (TVB-2640) significantly reduced liver fat content (the main therapeutic endpoint of the trial) with a response rate of 61% in the 50 mg dose group.
, the subjects also showed improvements in liver function and fibrosis indicators.
as the latest results of the ASC40 (TVB-2640) II. Phase II.1 data (Late Breaker) at the European Society of Hepatology (EASL) International Hepatology 2020 Annual Meeting (ILC) held online August 28, 2020.
ASC41 is an oral thyroid hormone-acceptor (THR-thyroid) astrogen, and its application for a clinical trial of NASH adaptation has recently been approved by China's State Drug Administration.
expects to have topline data on phase I safety, pharmacy and preliminary efficacy (LDL-C) in healthy volunteers with LDL-C greater than 110mg/dL by the end of 2020.
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