Phase II enrollment of ASC41(THRβ), an innovative pipeline drug developed by Lilly NASH, was successfully promoted

On December 21, 2022, the wechat official account of Kelley announced that the 52-week Phase II clinical trial of ASC41, a thyroid hormone receptor β (THRβ) agonist independently developed by its wholly-owned subsidiary Ganlai Pharmaceutical Co., Ltd. for the treatment of patients with non-alcoholic steatohepatitis (NASH) confirmed by liver biopsy, was successfully advanced. The Phase II clinical trial of ASC41, initiated by a Chinese biotechnology company, is the most advanced 52-week phase II clinical trial of NASH patients confirmed by liver biopsy. The first patient was enrolled in early October 2022. Full patient enrollment is expected to be completed by the end of the third quarter of 2023.

On December 19, 2022, Madrigal Pharmaceuticals, Inc. Phase III data from 52 weeks of Resmetirom (MGL-3196) therapy for NASH patients confirmed by liver biopsy were presented.

ASC41 is a liver-targeting precursor drug independently developed by Golly. Its active metabolites can selectively activate thyroid hormone receptor β (THRβ). In January 2021, Lilly announced that ASC41 completed a randomized, double-blind, placebo-controlled, single-dose and multiple-dose incremental Phase I trial in 65 subjects with low-density lipoprotein cholesterol (LDL-C) greater than 110 mg/dL. After 14 days of oral ASC41 tablets, LDL-C decreased significantly. In February 2021, Gurley announced promising clinical trial results for ASC41 in overweight and obese subjects.

In September 2021, the company completed a Phase I clinical trial of ASC41 oral tablets in healthy subjects on drug interactions and pharmacokinetics (PK) in patients with non-alcoholic fatty liver disease (NAFLD). ASC41 is metabolized mainly by CYP3A4 to form the active metabolite ASC41-A, which is A selective thyroid hormone receptor β agonist. The results of this clinical study suggest that antidepressants commonly used in the ASC41/ASC41-A and NASH populations (selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), Most of them were mild/moderate CYP3A4 inhibitors) with low likelihood of clinically significant drug interactions; The pharmacokinetic profile of ASC41/ASC41-A did not differ significantly between healthy subjects and patients with NAFLD.

About song rites

Kelley is an innovative R&D driven biotechnology company listed on the Hong Kong Stock Exchange (1672.HK), covering the complete value chain from new drug development to manufacturing and commercialization. Guided by a management team with deep expertise and a proven track record, Lilly focuses on three unmet clinical needs: viral diseases, non-alcoholic fatty liver disease and cancer, with a global perspective. With superior execution, Golly is rapidly advancing drug pipeline development and striving for a leading position in international competition. The company currently has three commercial products, Ritonavir tablets, Gonovir ® and Newlyl ®, and 22 drugs in development. Cutting-edge drug candidates include ASC22 (functional cure for hepatitis B), ASC10 and ASC11 (oral small-molecule anti-COVID-19 drugs), ASC40 (recurrent glioblastoma), ASC42 (primary biliary cholangitis), and ASC40 (acne).