Shanghai, China, 14 April 2021 -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces the dosing of the first cohort in the U.S. Phase I clinical study of drug interaction and non-alcoholic fatty liver disease (NAFLD) patient pharmacokinetics for ASC41 oral tablets, a liver-targeted prodrug. The active metabolite of ASC41 is a selective thyroid hormone receptor beta THR-β agonist.
On 25 February 2021, Gannex announced the Investigational New Drug Application (IND) approval by the U.S. Food and Drug Administration (FDA) for ASC41 oral tablets.
This clinical study consists of two cohorts: the first cohort is a drug-drug interaction study to evaluate the effect of itraconazole and phenytoin on the pharmacokinetics of ASC41 oral tablets in healthy volunteers, and the second cohort is a study to evaluate the pharmacokinetics, safety and tolerability of ASC41 oral tablets in patients with NAFLD.
Melissa Palmer, MD, Chief Medical Officer of Gannex, said, “We are excited about the dosing of the first cohort in the U.S. only one and half a months after IND approval by the FDA. This demonstrates the execution excellence of our clinical development team and the dedication of Gannex to the development of a drug for patients with NASH.”
Dr. Handan He, Chief Scientific Officer of Ascletis, said, “This study will offer important drug interaction information and pharmacokinetic data in patients with NAFLD which will accelerate our global clinical development for ASC41 oral tablets.”