Dong-A ST and Metavia Present Poster on Combination Therapy for MASH Treatment

At the ADA 2025 Conference Held on June 22 in the United States

On June 23, Dong-A ST and Metavia announced that they had presented the results of a preclinical study on the combination therapy of 'DA-1241,' currently under development as a treatment for MASH (Metabolic dysfunction-associated steatohepatitis), and the FGF21 analog 'Efruxifermin' at the American Diabetes Association (ADA 2025) conference held in Chicago, United States, on June 22.

DA-1241 is a first-in-class, orally administered synthetic drug that acts via the GPR119 mechanism. Animal studies have confirmed its effects on improving blood glucose and lipid levels, as well as its direct action on the liver to reduce inflammation and fibrosis. In December of last year, a Phase 2a clinical trial was completed in patients presumed to have MASH.

This study evaluated the efficacy of DA-1241 and Efruxifermin combination therapy in improving MASH using a mouse model induced with MASH. The study compared 12 weeks of combination therapy, each monotherapy, and a MASH control group. DA-1241 was administered orally once daily, while Efruxifermin was administered subcutaneously once weekly.

The results showed that in the group receiving both DA-1241 and Efruxifermin, approximately 94% of subjects experienced an improvement of at least 2 points in their NAFLD Activity Score (NAS) compared to baseline. In addition, the combination therapy group showed a significant reduction in liver fibrosis area compared to the untreated MASH control group, and some subjects exhibited a decrease in fibrosis stage compared to baseline.

During the 12-week drug administration period, DA-1241 did not have a significant effect on body weight, in contrast to Efruxifermin, which reduced body weight by approximately 17% compared to the MASH control group. Furthermore, in the combination therapy group, plasma ALT levels and liver lipid levels decreased more than in either monotherapy group, without causing additional weight loss.

The combination therapy of DA-1241 and Efruxifermin significantly improved the expression of hepatic genes involved in inflammation and fibrosis compared to the MASH control group, and also reduced levels of glycemic inflammatory markers.

Previously announced results from the global Phase 2 clinical trial of DA-1241 demonstrated statistically significant hepatoprotective effects. Improvements were observed in baseline ALT (Alanine Aminotransferase, a liver injury marker), CAP (Controlled Attenuation Parameter, a marker of fatty liver used to assess MASH progression), MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction, a marker of liver fat content), NIS-4 (Non Invasive Score-4, a liver disease risk marker), and the non-invasive FAST (FibroScan-AST, a liver fibrosis marker).

Efruxifermin is a recombinant protein designed as FGF21 (Fibroblast Growth Factor 21), a hormone secreted by the liver, and has anti-inflammatory effects, regulates blood glucose, promotes weight loss, and modulates lipid metabolism. Global clinical trials are currently underway targeting metabolic diseases such as MASH, obesity, and type 2 diabetes.

A representative from Dong-A ST stated, "We are conducting combination clinical trials with various drugs to develop a differentiated MASH treatment, and this study confirmed that the combination therapy of DA-1241 and Efruxifermin is more effective for MASH treatment. We will continue with subsequent clinical trials of DA-1241 and various combination studies to develop a treatment that can lead the global MASH market."

Meanwhile, the American Diabetes Association (ADA) is the world's most prestigious academic conference for sharing the latest research in metabolic diseases, including diabetes, obesity, and MASH. This year's event was held in Chicago, United States, from June 20 to June 23.