Gan Lai announced the completion of the first cohort dosing in the U.S. clinical study of THR-β agonist ASC41

Gan Lai Pharmaceutical is a wholly-owned subsidiary of Golly Pharmaceutical Co.
, Ltd.
(Hong Kong Stock Exchange code: 1672), which focuses on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis (NASH)
.

The clinical trial application (IND) was approved by the U.
S.
Food and Drug Administration (FDA) on February 25, 2021
.

The clinical study consisted of two cohorts: cohort one was a drug interaction (DDI) study to evaluate the effects of itraconazole and phenytoin on the pharmacokinetics of ASC41 oral tablets in healthy volunteers; cohort two It is a study to evaluate the pharmacokinetics, safety and tolerability of ASC41 oral tablets in patients with non-alcoholic fatty liver disease
.

Dr.
Melissa Palmer, Chief Medical Officer of Kam Lai Pharmaceuticals, said: “I am very pleased that only one and a half months after the U.
S.
Food and Drug Administration approved the ASC41 clinical trial application, we completed the first cohort of drug delivery, which proves that our clinical development team has excellence.
The executive power of the company, and Gan Lai’s determination and efforts to develop innovative drugs for patients with non-alcoholic steatohepatitis
.

       Dr.
Hanhan He, Chief Scientific Officer of Gallée, said: “This study will provide us with important drug interaction and pharmacokinetic data for patients with non-alcoholic fatty liver disease.
The results of these studies will support us in accelerating the development of ASC41 oral tablets.
Global clinical development process
.