Vimgreen Pharmaceuticals, a Chinese developer of novel therapeutics targeting adenosine signalling pathways, with a focus on addressing unmet medical needs in neurodegenerative, metabolic, and inflammatory diseases, announced on Saturday that China's Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application for VG081821 in non-alcoholic steatohepatitis (NASH), increasingly referred to as metabolic dysfunction-associated steatohepatitis (MASH).

This represents the second clinical indication for the company's lead drug candidate, complementing its ongoing development program for Parkinson's disease.

This is the first global clearance of an A2A receptor antagonist for NASH clinical investigation. VG081821 can proceed directly to Phase II NASH trials, significantly shortening the clinical development timeline for this potential breakthrough therapy.

NASH is a progressive liver disease characterised by excessive fat accumulation (steatosis), hepatocellular injury, inflammation, and progressive fibrosis. With obesity and metabolic syndrome reaching epidemic proportions worldwide, NASH has emerged as a leading cause of cirrhosis and hepatocellular carcinoma.

However, Vimgreen noted that despite its increasing prevalence and severe clinical consequences, the therapeutic landscape remains highly limited: to date, only two pharmacological agents -- resmetirom and semaglutide -- have been granted merely accelerated approval, underscoring a critical unmet need for additional effective treatment options.

VG081821 simultaneously targets the three core pathological features of NASH: steatosis, inflammation, and fibrosis. The company expects to commence a Phase IIa trial for NASH treatment in the second half of the year.