Dong-A ST announced on the 8th that its U.S. subsidiary, Metavia, presented the Phase 2 clinical trial results of its investigational treatment for metabolic dysfunction-associated steatohepatitis (MASH), 'DA-1241', in a poster session at the European Association for the Study of the Liver (EASL) Congress held in Amsterdam, the Netherlands, from May 7 to 10.
In the global Phase 2 clinical trial, DA-1241 was randomly assigned to 109 MASH patients in four groups: 50mg and 100mg monotherapy groups, a 100mg plus DPP4 inhibitor combination therapy group, and a placebo group. The drug was administered once daily for 16 weeks to evaluate its efficacy and safety. MASH, also known as nonalcoholic steatohepatitis (NASH), is a condition characterized by the accumulation of neutral fat in liver cells unrelated to alcohol consumption.
As a result, patients with liver injury markers (ALT) between 40 and 200 units per liter (U/L) showed a reduction in ALT levels depending on the dosage, with the 100mg group experiencing an average decrease of 22.8 U/L.
The company also reported improvements in other indicators used to assess MASH progression, including the FibroScan-AST (FAST) score for liver fibrosis, the controlled attenuation parameter (CAP) for fatty liver, the proton density fat fraction (PDFF) for liver fat content, and the NIS-4 score for liver disease risk.
In particular, the company explained that in the 100mg group, there were significant reductions in inflammatory markers such as hs-CRP and CCL2, the fibrosis marker TIMP1, and the hepatocyte apoptosis marker cytokeratin 18.
The company added that, along with liver-protective effects, DA-1241 also produced a statistically significant reduction in blood glucose, as evidenced by decreased glycated hemoglobin (HbA1c). Additionally, except for one case in the placebo group, no adverse events were observed after treatment, confirming the drug's safety profile.
Kim Hyeongheon, CEO of Metavia, stated, "DA-1241 has proven to be the first oral GPR119 agonist to demonstrate both liver-protective and blood glucose-lowering effects in MASH patients through global Phase 2 clinical trials." He added, "We plan to conduct a data review with the U.S. Food and Drug Administration (FDA) in the first half of this year to complete Phase 2 clinical studies."
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