Gannex, a wholly owned company of Ascletis Pharma Inc (HKEX: 1672), announced on Wednesday that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application and initiation of global development of ASC41 oral tablet, a liver-targeted prodrug.
The product is a selective thyroid hormone receptor beta (THR-beta) agonist.
The approval was based on efficacy and safety data from the phase one randomised, double-blind, placebo controlled single- and multiple-ascending dose study in 65 patients completed in China and commercially ready oral tablet formulation developed with in-house proprietary technology.
The approval allows the firm to commence clinical trials in the United States.
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