Gannex announces dosing 1st subject with NASH candidate in Phase 1 trial

The trial would enable the company to evaluate tolerability, safety, and effects of ASC42 in healthy subjects

Amidst umpteen clinical trials ongoing in the world, Gannex Pharma Co., Ltd., an Ascletis Pharma company that is focused on the research and development and commercialization of new drugs in the field of NASH, has recently announced dosing its first subject with NASH drug candidate ASC42, in a U.S Phase 1 trial.

For the record, ASC42 is an in-house developed, non-steroidal, potent and selective FXR (Farnesoid X Receptor) agonist. The drug candidate had potentially received Fast Track designation from the U.S. Food and Drug Administration for NASH. It has been claimed that the oral tablet formulation for this drug has been developed with the in-house patented technology and is considered to be stable at room temperature.

Commenting on the matter, Chief Scientific Officer of Ascletis, Dr. Handan He reportedly cited that the company is delighted about the initiation of U.S Phase 1 trial for the novel drug candidate- ASC42- in 2020. He considers this trial to be an important milestone for the company’s R&D team that explored and developed ASC42, with the potential to be one of the best-in class FXR agonists for NASH.

On the other hand, Melissa Palmer, MD, CMO of Gannex, quoted that as a novel FXR agonist- ASC42 has displayed brilliant preclinical anti-fibrotic and anti-inflammatory effect. She added that merging ASC42 with ASC40 or ASC41 would offer exciting yet beneficial therapeutic options for NASH patients in the years to come.

The U.S. Phase 1 trial is double-bling, placebo-controlled, randomized, single and multiple dose study amended to understand and evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of NASH drug candidate- ASC42 in healthy subjects. The trial also stands crucial in better investigating the food effect on ASC42 exposure.

Source Credit: https://www.prnewswire.com/news-releases/first-subject-dosed-with-gannexs-fxr-agonist-asc42-in-a-us-phase-i-trial-301198537.html