CureGene has dosed the first participant in an Australian Phase I clinical trial of CG-0416, an investigational oral liver-targeting thyroid hormone receptor beta agonist.
The candidate was developed using CureGene’s proprietary prodrug platform and is designed to achieve high release of its active component within the liver while maintaining low systemic exposure.
The approach is intended to reduce potential off-target effects in tissues outside the liver.
CureGene is developing CG-0416 for metabolic conditions associated with excessive liver fat and broader metabolic dysfunction.
Preclinical studies reported reductions in liver fat together with improvements in lipid profiles and glucose tolerance.
The company also reported that CG-0416 demonstrated reductions in body weight in preclinical studies while preserving muscle mass.
CureGene said the weight-loss effect observed in its preclinical programme was comparable with that seen with GLP-1 receptor agonists such as semaglutide, although these findings have yet to be demonstrated clinically.
The Phase I programme will provide the first human data on the candidate and is expected to assess its safety, tolerability, pharmacokinetics and pharmacodynamic properties.
The first-participant dosing marks the transition of CG-0416 from preclinical development into clinical evaluation.
CureGene said participant enrolment in Australia is continuing as it advances development of the candidate for metabolic and liver-related diseases.
