Gannex Pharma has dosed the first subject in a Phase II clinical trial of ASC42 for the treatment of primary biliary cholangitis (PBC) patients. 

The trial subjects will be categorised into a 1:1:1:1 ratio to receive 5mg, 10mg and 15mg doses of ASC42 or placebo.

It will enrol 100 subjects with an inadequate response to or are not able to tolerate ursodeoxycholic acid (UDCA) into three active treatment arms or one placebo control arm of the trial.

With a treatment duration of 12 weeks, the trial is anticipated to conclude by the end of this year.

ASC42 is a farnesoid X receptor (FXR) agonist. Gannex is a subsidiary of Ascletis Pharma.

In November last year, the China National Medical Products Administration (NMPA) granted approval to the protocol of the Phase III trial to be conducted on 210 PBC patients.

On concluding the Phase II trial, Gannex intends to launch the Phase III trial in the US, China and European Union following talks with the NMPA on matters linked to drug registration such as Chemistry, Manufacturing and Control (CMC) and toxicology studies.

According to findings from the Phase I trial of ASC42 in the US, no pruritus was reported during a 14-day treatment with a 15mg once-a-day dose of the therapy.

Furthermore, a 1,780% rise in FXR target engagement biomarker Fibroblast Growth Factor 19 (FGF19) was reported on day 14. 

The mean low density lipoprotein-cholesterol (LDL-C) values were found to be within the normal range during the treatment period.

Ascletis founder, chairman and CEO Dr Jinzi Wu said: “We are excited ASC42 Phase II trial for PBC is on track. 

“Once again, it demonstrated the execution excellence of our clinical team. We are working very hard to transform ourselves into a global R&D leader in hepatobiliary diseases.”

In February last year, Gannex reported positive data from a trial of its liver-targeted prodrug, ASC41, in overweight and obese participants with high LDL-C.