MetaVia Reports Promising Phase 2a Trial Results for DA-1241 in Patients with MASH
MetaVia Inc., a clinical-stage biotechnology firm, has just released positive results from its Phase 2a clinical trial focusing on DA-1241, a groundbreaking therapeutic aimed at treating patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). This two-part trial explored DA-1241’s effectiveness compared to a placebo, revealing substantial benefits for patients receiving the treatment, particularly regarding liver function and glucose levels.
The Phase 2a trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, involved a total of 109 participants who were randomized into two groups. The first part assessed the efficacy of DA-1241 against placebo, while the second part evaluated its effectiveness in conjunction with sitagliptin, a recognized DPP-4 inhibitor. The trial's primary focus was the reduction of alanine transaminase (ALT) levels, a key indicator of liver health.
Results for those treated with 100mg of DA-1241 showed a statistically significant reduction in ALT levels at weeks four and eight, with notable improvements also observed at week 16—a promising sign given the treatment's potential to mitigate liver inflammation. Alongside ALT improvements, participants benefitted from statistically significant reductions in controlled attenuation parameter (CAP) scores—indicative of liver fat content—and hemoglobin A1c (HbA1C) levels, underlining DA-1241's role in improving metabolic health.
Secondary endpoints also reinforced the primary findings, highlighting that a higher proportion of subjects taking DA-1241 achieved normalized ALT levels compared to the placebo group. The safety profile of DA-1241 was impressive, featuring primarily mild adverse events with no severe complications, emphasizing the treatment's tolerability.
Hyung Heon Kim, President and CEO of MetaVia, commented on the results, stating, "Achieving the primary endpoint of reducing ALT levels through direct hepatic effects—along with significant reductions in HbA1C—is extremely encouraging, especially given the small scale of the study." MetaVia is committed to advancing DA-1241 through clinical evaluations and anticipates discussions with the U.S. Food and Drug Administration regarding Phase 2 developments in the coming months.
In parallel to its pharmacological effects, DA-1241 stimulates the release of various gut peptides linked to glucose metabolism, making it an exciting prospect for patients managing conditions like MASH and type 2 diabetes (T2D). Such a dual mechanism of action could significantly improve patient outcomes by targeting both liver health and metabolic regulation.
As further data emerges—from additional exploratory endpoints like MRI-PDFF—and preparations for scientific conferences unfold, MetaVia is striving to position DA-1241 as a safe and effective treatment alternative for individuals grappling with MASH. Transitioning from encouraging trial findings toward real-world applications of DA-1241 could herald a new era in the treatment of cardiometabolic diseases, potentially transforming lives for those affected by these complex conditions.
For detailed information about the study, visit www.clinicaltrials.gov and search using the identifier NCT06054815. By monitoring the ongoing journey of DA-1241, stakeholders and patients alike can look forward to engaging advancements in the quest for effective treatments against liver-related diseases.
The Phase 2a trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, involved a total of 109 participants who were randomized into two groups. The first part assessed the efficacy of DA-1241 against placebo, while the second part evaluated its effectiveness in conjunction with sitagliptin, a recognized DPP-4 inhibitor. The trial's primary focus was the reduction of alanine transaminase (ALT) levels, a key indicator of liver health.
Results for those treated with 100mg of DA-1241 showed a statistically significant reduction in ALT levels at weeks four and eight, with notable improvements also observed at week 16—a promising sign given the treatment's potential to mitigate liver inflammation. Alongside ALT improvements, participants benefitted from statistically significant reductions in controlled attenuation parameter (CAP) scores—indicative of liver fat content—and hemoglobin A1c (HbA1C) levels, underlining DA-1241's role in improving metabolic health.
Secondary endpoints also reinforced the primary findings, highlighting that a higher proportion of subjects taking DA-1241 achieved normalized ALT levels compared to the placebo group. The safety profile of DA-1241 was impressive, featuring primarily mild adverse events with no severe complications, emphasizing the treatment's tolerability.
Hyung Heon Kim, President and CEO of MetaVia, commented on the results, stating, "Achieving the primary endpoint of reducing ALT levels through direct hepatic effects—along with significant reductions in HbA1C—is extremely encouraging, especially given the small scale of the study." MetaVia is committed to advancing DA-1241 through clinical evaluations and anticipates discussions with the U.S. Food and Drug Administration regarding Phase 2 developments in the coming months.
In parallel to its pharmacological effects, DA-1241 stimulates the release of various gut peptides linked to glucose metabolism, making it an exciting prospect for patients managing conditions like MASH and type 2 diabetes (T2D). Such a dual mechanism of action could significantly improve patient outcomes by targeting both liver health and metabolic regulation.
As further data emerges—from additional exploratory endpoints like MRI-PDFF—and preparations for scientific conferences unfold, MetaVia is striving to position DA-1241 as a safe and effective treatment alternative for individuals grappling with MASH. Transitioning from encouraging trial findings toward real-world applications of DA-1241 could herald a new era in the treatment of cardiometabolic diseases, potentially transforming lives for those affected by these complex conditions.
For detailed information about the study, visit www.clinicaltrials.gov and search using the identifier NCT06054815. By monitoring the ongoing journey of DA-1241, stakeholders and patients alike can look forward to engaging advancements in the quest for effective treatments against liver-related diseases.
Topics Health）
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