South Korean pharmaceutical company OliX Pharmaceuticals has dosed the first subject in a Phase I clinical trial of OLX75016, a new drug candidate intended to treat metabolic dysfunction-associated steatohepatitis (MASH).
The trial will assess the safety and tolerability of OLX75016 in a randomised, double-blind, placebo-controlled setting.
Its first participant was dosed in Brisbane, Australia.
Both single and multiple ascending doses of the therapy will be administered to healthy volunteers and patients who are in the early stages of non-alcoholic fatty liver disease.
OLX75016 acts as a mechanism to reduce liver fat content, inflammation and liver fibrosis, which is often seen in obese patients.
The drug's development is informed by Genome-Wide Association Study (GWAS) data, which suggests that specific genes play a key role in these processes.
This genetic evidence has been supported by non-clinical research.
OliX also presented data suggesting that OLX75016 could be effective as both a single agent and in combination with other agents for the management of MASH and weight.
The company focuses on developing therapies for various disorders by inhibiting the expression of genes that cause disease through its ribonucleic acid interference technology.
OliX Pharmaceuticals founder and CEO Dong Ki Lee said: “With the obesity market expected to reach $100bn by 2030, many companies opt to develop GLP-1/GIP agonists for their weight management therapies.
“Given a differentiated mechanism of action, OLX75016 demonstrates its robust multimodality potential not just for additive weight loss effects but for NASH and liver fibrosis alleviation.
“This is how we believe OLX75016 is set apart, and we anticipate this novel therapeutic to bring hope to patients with multiple metabolic diseases, starting in Phase I clinical trial.”
Last December, OliX received approval from the Alfred Human Research Ethics Committee (HREC) to begin the Phase I trial of OLX75016 for NASH treatment.