{"id":847818,"date":"2025-05-07T02:04:53","date_gmt":"2025-05-07T06:04:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/metavia-presents-data-on-da-1241-a-gpr119-agonist-demonstrating-both-hepatoprotective-and-glucose-regulating-effects-in-patients-with-presumed-mash-at-the-easl-congress-2025\/"},"modified":"2025-05-07T02:04:53","modified_gmt":"2025-05-07T06:04:53","slug":"metavia-presents-data-on-da-1241-a-gpr119-agonist-demonstrating-both-hepatoprotective-and-glucose-regulating-effects-in-patients-with-presumed-mash-at-the-easl-congress-2025","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/metavia-presents-data-on-da-1241-a-gpr119-agonist-demonstrating-both-hepatoprotective-and-glucose-regulating-effects-in-patients-with-presumed-mash-at-the-easl-congress-2025\/","title":{"rendered":"MetaVia Presents Data on DA-1241, a GPR119 Agonist, Demonstrating Both Hepatoprotective and Glucose-Regulating Effects in Patients with Presumed MASH, at the EASL Congress 2025"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n DA-1241 Significantly Decreased Plasma ALT levels, with a Mean Reduction of 22.8 U\/L After 16 Week-Treatment <\/i>\n <\/p>\n

\n Controlled Attenuation Parameter (CAP) Score Improved by 23.0 dB\/m, Indicating Reduced Liver Fat Content<\/i>\n <\/p>\n

\n Improvement in Systemic Inflammatory and Fibrosis Biomarkers Supports Beneficial Effects on Liver Health<\/i>\n <\/p>\n

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\n CAMBRIDGE, Mass.<\/span>
\n <\/span>, May 7, 2025<\/span><\/span> \/PRNewswire\/ — MetaVia Inc. <\/b>(Nasdaq: MTVA),\u00a0a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), demonstrates both hepatoprotective and glucose-regulating effects. The data will be presented in late-breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place May 7-10, 2025<\/span>, in Amsterdam, the Netherlands<\/span>.<\/p>\n

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A total of 109 subjects with presumed MASH and qualifying baseline alanine transaminase (ALT) and imaging analysis were randomized to receive DA-1241 50 mg, DA-1241 100 mg alone, DA-1241 100 mg with a dipeptidyl peptidase 4 inhibitor (DPP4i), or placebo (PBO) in a 1:2:2:2 ratio, once daily for 16 weeks. The primary efficacy endpoint was the change from baseline in ALT after 16 weeks of treatment.<\/p>\n

“The full data from our Phase 2 clinical study, as presented at the prestigious EASL Congress, confirm that DA-1241 is the first oral GPR119 agonist to demonstrate both hepatoprotective and glucose-regulating effects in presumed MASH patients,” stated Hyung Heon Kim<\/span>, President and Chief Executive Officer of MetaVia. “Importantly, treatment with DA-1241 significantly reduced key markers of liver injury, inflammation, and fibrosis, while also improving non-invasive liver assessments such as CAP and FibroScan-AST (FAST) scores. In addition, DA-1241 efficiently improved glycemic control in patients with comorbid prediabetes and type 2 diabetes. DA-1241 was well tolerated across patient groups, with a favorable safety profile. These results suggest that DA-1241’s hepatoprotective effects are likely driven by its anti-inflammatory and anti-fibrotic actions rather than just glucose lowering, offering a promising multi-faceted therapeutic approach for patients at risk of progressive liver disease. Based on this data, we continue to believe that the novel mechanism of action of DA-1241 supports further development as either a monotherapy or combination therapy for MASH and metabolic diseases. We continue to conduct pre-clinical studies to explore other combination therapies for DA-1241, which may provide additional benefits to treat patients along the full spectrum on MASH. We look forward reviewing these findings at an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025.”<\/p>\n

In subjects with baseline ALT levels between 40 and 200 U\/L, DA-1241 treatment led to dose-dependent reductions in ALT, with the 100 mg dose producing a significant 22.8 U\/L decrease after 16 weeks (p < 0.05 vs. placebo). These effects were observed regardless of diabetes status and were accompanied by improvements in non-invasive tests (NITs) used to monitor MASH progression such as FAST, CAP, MRI-PDFF and NIS-4<\/span> score. Specifically, the average FAST score declined from 0.559 to 0.371, indicating improvements in liver fibrosis and fat accumulation. Liver fat, measured by CAP, was reduced by 23.0 dB\/m with DA-1241 100 mg compared to just 1.4 dB\/m with placebo.<\/p>\n

Importantly, the 100 mg dose significantly lowered biomarkers of systemic inflammation (hs-CRP, CCL2) and fibrosis (TIMP1) (p < 0.05 vs. placebo), consistent with results from MASH mouse studies. Cytokeratin 18, a marker of liver cell death, also decreased significantly by 30.5% (p < 0.05 vs. placebo).<\/p>\n

Beyond liver-related outcomes, DA-1241 100 mg produced rapid and significant reductions in hemoglobin A1c (HbA1c) of 0.37%p, 0.41%p, and 0.54%p at weeks 4, 8, and 16, respectively, from a baseline of 6.99%\u2014despite nearly half of the participants being non-diabetic (p < 0.05 vs. placebo). In the subgroup of presumed MASH patients with type 2 diabetes, HbA1c decreased by 1.08%p. When 100 mg DA-1241 was co-administered with a DPP4 inhibitor pill preventing degradation of endogenous GLP-1<\/span>, metabolic benefits were further enhanced without causing weight loss.<\/p>\n

DA-1241 was well tolerated among presumed MASH patients, with no treatment-emergent adverse events (TEAEs) leading to discontinuation, except for one case in the placebo group.<\/p>\n

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\n Presentation Details:<\/b>\n <\/p>\n