Chinese biopharmaceutical company Shenzhen Chipscreen Biosciences has reported positive outcomes from the Phase II CGZ203 trial of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH).
The randomised, placebo-controlled study was conducted across 24 clinical sites in China and was led by Beijing Friendship Hospital affiliated to Capital Medical University.
It aimed to assess chiglitazar's safety and initial efficacy in patients with NASH.
Patients were randomised into a 2:2:1 ratio to receive oral chiglitazar at doses of 48mg and 64mg, or a placebo, once a day for 18 weeks.
The percentage change from baseline in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction after 18 weeks was the trial’s primary efficacy endpoint.
Its secondary endpoints were the absolute value of LFC changes, the proportion of subjects experiencing a decline of more than 30% in LFC, and changes in other non-invasive indicators of liver cell damage, inflammation and fibrosis.
Results showed that the trial met its primary efficacy endpoint, with further data analysis currently in progress.
Both dosage groups of chiglitazar demonstrated significant and dose-dependent reductions at the primary efficacy endpoint versus placebo.
Chiglitazar also caused significant or dose-dependent trends of improvement on secondary efficacy endpoints of the trial.
The drug's overall safety profile was reported as good.
A peroxisome proliferator activation related receptor (PPAR) pan-agonist, chiglitazar received approval in China in October 2021 for treating type 2 diabetes patients.
Earlier this year, Chipscreen NewWay dosed the first subject in a Phase I trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001.
The non-randomised, open-label trial is designed to assess the safety, tolerability, preliminary efficacy, pharmacokinetic properties and potential biomarkers linked to NWY001 treatment in advanced solid tumour patients.
NWY001 is understood to be the world's first PD-1/CD40 bispecific antibody to enter clinical studies.
