Chinese biotechnology company Gannex Pharma has finished enrolling patients in the Phase II clinical trial of ASC42 for the treatment of primary biliary cholangitis (PBC).

The study enrolled a total of 98 patients, who will be divided into three active treatment arms and one placebo control arm.

Patients in the treatment arm will receive 5mg, 10mg and 15mg dosages of ASC42 for 12 weeks.

They were selected for the study based on the inadequate responses shown when being treated with Ursodeoxycholic acid (UDCA).

Topline data from the study are expected by the end of this year.

No pruritus was observed during 14 days of treatment with 15mg ASC42, as demonstrated in a Phase I trial carried out in the US.

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Fibroblast Growth Factor 19 (FGF19), a FXR target engagement biomarker, increased by 1,780% in patients treated with the 15mg dosage on day 14.

In addition, the mean values of low-density lipoprotein cholesterol (LDL-C) were within the normal range.

An estimated 120,000 patients in the US have PBC, according to an epidemiology study conducted in 2014.

Obeticholic acid (OCA) is currently the only medicine in the US that is approved to treat PBC patients who cannot tolerate UDCA.

Ascletis has developed more than 20 drugs, including ASC10 for treating RSV infection, ASC22 for CHB functional cure and ASC40 for acne.

The company’s portfolio also includes ASC40 for recurrent glioblastoma, ASC40 and ASC41 for NASH, and ASC61 for advanced solid tumours.

Based in Hangzhou, Gannex Pharma is a wholly owned subsidiary of Ascletis Pharma.

Ascletis Pharma chairman and CEO Jinzi J Wu said: “We are excited that ASC42 for PBC has completed the patient enrollment for the Phase II clinical trial.

“We are working very hard to complete this Phase II trial by the end of 2023.”