Ascletis Pharma Inc. announced that the poster presentation titled, "ASC41, a selective THRb agonist significantly reduces liver fat and ALT in biopsy- confirmed MASH patients after 12-week treatment: an interim analysis of a 52-week serial liver biopsy study", describes significant and clinically meaningful reductions in liver fat, alanine aminotransferase (ALT) and aspartate aminotransferase ("AST") in biopsy-confirmed MASH patients receiving 12-week treatment of ASC41 tablet, among which the data of ALT and AST notably differentiates ASC41 from other thyroid hormone receptor b (THRb) agonists currently at clinical or commercial stages. In addition, baseline characteristics from Phase II clinical trials were comparable between ASC41, conducted in China, and resmetirom, except for lower body mass index (BMI) and more males for ASC41. ASC41, a once-daily oral tablet, is a liver targeted small molecule and is highly THRb-selective.

The oral tablet formulation was developed utilizing Ascletis' in-house proprietary technology. Three Phase I or Ib studies in China were completed in healthy or obese subjects with elevated low-density lipoprotein cholesterol (LDL-C) > 110 mg/dL. Results from the Phase II clinical trial, were completed in healthy or obesity subjects with elevated low-density Lipoprotein cholesterol (LDL -C) > 110 mg/L. Results from Phase II clinical trials were achieved in the Phase II clinical trial.

The randomized, double-blind, placebo-controlled and multi-center Phase II clinical trial (Closing) was completed in the Phase II clinical trial, including the placebo cohort (see Table 3). No treatment-related serious adverse event (SAE) was reported in any patients receiving ASC41 treatment or placebo. The patent of ASC41 tablet formulation has been granted in the U.S. About the Phase II Clinical Trial.

The randomized, double- blind, placebo-controlled and multi -center Phase II clinical trial (Closing) was reported in the U.S.