MetaVia Announces Statistically Significant Reduction in Uric Acid Levels with DA-1726 in Phase 1 Part 3B Clinical Trial

The uric acid analysis involved 15 DA-1726 recipients and four placebo participants, with mean baseline levels already normal.

Rhea-AI Summary

MetaVia (Nasdaq: MTVA) reported a statistically significant reduction in uric acid with DA-1726 in its Phase 1 Part 3B interim analysis. After 16 weeks, the placebo-adjusted reduction was 1.47 mg/dL (p<0.001), despite normal mean baseline levels. The analysis included 15 treated participants and four receiving placebo, all otherwise healthy adults with obesity.

Previously reported results included 68.1% placebo-adjusted liver fat reduction, 13.5% placebo-adjusted weight loss and a 0.44 absolute percentage-point reduction in HbA1c, a blood-sugar measure. All five treated participants with baseline liver fat accumulation reached liver fat below 5% by Day 109. MetaVia expects full Part 3A and 3B data in the first quarter of 2027 and plans a 48-week, non-biopsy Phase 2 study in up to 150 subjects with metabolic and alcohol-associated liver disease or alcohol-associated liver disease, targeting the second half of 2027.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointDA-1726 reduced uric acid by 1.47 mg/dL versus placebo after 16 weeks (p<0.001).
• Moderate pointPreviously reported liver fat reduction reached 68.1% versus placebo in the Part 3B interim analysis (p<0.001).
• Moderate pointPreviously reported weight loss reached 13.5% versus placebo in the Part 3B interim analysis (p<0.001).
• Moderate pointHbA1c, a blood-sugar measure, declined 0.44 absolute percentage points in previously reported interim results (p=0.006).
• Moderate point. Forward-looking: it has not happened yet and may not happen.MetaVia plans a 48-week Phase 2 study in up to 150 subjects, targeting the second half of 2027.

2 minor points

• Minor pointAll five treated participants with baseline liver fat accumulation reached liver fat below 5% by Day 109.
• Minor point. Forward-looking: it has not happened yet and may not happen.MetaVia expects full Part 3A and Part 3B data in the first quarter of 2027.

Negative

• Minor pointInterim uric acid findings cover only 15 treated participants and four placebo participants, all otherwise healthy adults with obesity.

Key Figures

Uric-acid reduction: 1.47 mg/dL placebo-adjusted (95% CI: −2.0 to −0.9; p<0.001) Interim analysis participants: 15 DA-1726-treated; 4 placebo Liver-fat reduction: 68.1% placebo-adjusted +1 more

Uric-acid reduction

1.47 mg/dL placebo-adjusted (95% CI: −2.0 to −0.9; p<0.001)

After 16 weeks of DA-1726 treatment

Interim analysis participants

15 DA-1726-treated; 4 placebo

Phase 1 Part 3B

Liver-fat reduction

68.1% placebo-adjusted

Previously reported Phase 1 Part 3B interim result

Planned Phase 2 study

Up to 150 subjects; 48 weeks

Non-biopsy study in MetALD and ALD, targeted for the second half of 2027

Previous Clinical trial Reports

1 past event · Latest: Nov 05

Same Type 1 event

1. Nov 05

   Phase 1 clinical data

   24h Move

   -18.7%

   Earlier Part 3B interim report quantified liver-fat, weight and HbA1c changes; latest adds uric-acid endpoint.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

oxyntomodulin, glp1r, hba1c, mri-pdff

4 terms

oxyntomodulin medical

"a novel oxyntomodulin (OXM) analog targeting both GLP-1"

Oxyntomodulin is a naturally occurring gut hormone released after eating that reduces appetite and influences blood sugar and energy use, acting like a thermostat that helps dial down hunger and adjust the body's fuel handling. It matters to investors because drugs that mimic or boost this hormone are a major class of experimental treatments for obesity and diabetes; trial results, safety findings, and regulatory decisions around oxyntomodulin-based therapies can strongly affect company value and market opportunity.

glp1r medical

"targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors"

A GLP‑1 receptor is a protein on certain cells that responds to the hormone GLP‑1, helping control blood sugar and appetite; drugs that activate this receptor can lower glucose and promote weight loss. Investors watch GLP‑1 receptor (GLP‑1R) drugs because successful medicines targeting it can command large markets, shift treatment standards, and drive sales, regulatory reviews, and partnership or acquisition activity — like finding a better key for an important lock.

hba1c medical

"a 0.44 absolute percentage-point reduction in HbA1c"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

mri-pdff medical

"achieved MRI-PDFF below 5% by Day 109"

MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction) is a medical imaging technique that measures the amount of fat within the liver or other tissues. For investors, it provides a precise way to assess health risks related to fat buildup, which can impact healthcare costs and the valuation of related companies. Its accuracy helps in monitoring treatment progress and predicting potential medical expenses, making it relevant for healthcare decision-making and investment considerations.

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Adding to Previously Reported 68.1% Liver Fat Reduction and Strengthening Its Liver Profile for MetALD

Additional Phase 1 Part 3B Data Highlight DA-1726's 1.47 mg/dL Placebo-Adjusted Reduction in Uric Acid After 16 Weeks of Treatment (p<0.001), Despite Normal Mean Uric Acid Levels at Baseline

Normalization of Liver Fat in All Subjects with Baseline Steatosis, 13.5% Placebo-Adjusted Weight Loss and Improvements in HbA1c

MetaVia Advancing DA-1726 Toward Planned Phase 2 Study in MetALD and ALD in the Second Half of 2027

CAMBRIDGE, Mass., Nov. 12, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming liver-related cardiometabolic diseases, today announced additional positive data from the previously reported interim analysis of Part 3B of its Phase 1 clinical trial of DA-1726, a novel oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors. The results demonstrated a statistically significant 1.47 mg/dL placebo-adjusted reduction in serum uric acid from baseline (p<0.001) following 16 weeks of once-weekly DA-1726 treatment in otherwise healthy adults with obesity.

"These additional findings further strengthen the metabolic profile emerging for DA-1726 and provide another encouraging signal as we advance its development in liver-related cardiometabolic diseases," said Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "The statistically significant reduction in uric acid is particularly noteworthy given that participants entered the study with mean levels already within the normal range. Elevated uric acid has been associated with liver fat accumulation, insulin resistance and alcohol consumption, making these findings particularly relevant to our focus on MetALD and ALD. Combined with the previously reported significant reductions in liver fat, body weight and HbA1c, these results reinforce our belief that DA-1726 has the potential to deliver benefits beyond weight loss alone."

At Day 109, mean serum uric acid levels in DA-1726-treated participants decreased by 1.02 mg/dL from a baseline of 5.89 mg/dL (p<0.001), compared with a 0.45 mg/dL increase from a baseline of 4.80 mg/dL in the placebo group. The resulting placebo-adjusted reduction of 1.47 mg/dL was statistically significant (95% CI: −2.0 to −0.9; p<0.001). The analysis included 15 participants treated with DA-1726 and four receiving placebo. The findings complement previously reported Part 3B interim results demonstrating a statistically significant 68.1% placebo-adjusted reduction in liver fat (p<0.001), 13.5% placebo-adjusted weight loss (p<0.001) and a 0.44 absolute percentage-point reduction in HbA1c (p=0.006). In addition, all five DA-1726-treated participants with liver steatosis at baseline achieved MRI-PDFF below 5% by Day 109.

Mr. Kim concluded, "We believe the dual GLP-1 and glucagon receptor agonism of DA-1726, together with the robust effects observed across multiple metabolic parameters, provides a compelling foundation for further clinical development. We expect to report full data from Part 3A and Part 3B in the first quarter of 2027 and are planning a 48-week, non-biopsy Phase 2 study in up to 150 subjects with MetALD and ALD, targeted to begin in the second half of 2027."

About the DA-1726 Phase 1 Part 3B Study
Part 3B of the Phase 1 trial of DA-1726 is a 16-week, randomized, placebo-controlled study in otherwise healthy adults with obesity. Participants receiving DA-1726 were titrated from 16 mg for 4 weeks, to 32 mg for 4 weeks, to the target dose of 64 mg, administered once weekly by subcutaneous injection. The interim analysis includes 15 participants treated with DA-1726 and four treated with placebo; an MRI substudy of 12 DA-1726-treated and four placebo participants assessed liver fat by MRI-PDFF and body composition.

About DA-1726
DA-1726 is a novel GLP1R/GCGR dual agonist being developed to address various cardiometabolic indications, with potential in both Metabolic and Alcohol-Associated Liver Disease (MetALD) and Alcohol-Associated Liver Disease (ALD), which is designed for once weekly, subcutaneous administration. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. It is engineered with a 3:1 GLP1R:GCGR potency ratio intended to balance the complementary effects of GLP1R activation on appetite and glucose control with GCGR activation on energy expenditure and fat breakdown. DA-1726 has a well understood mechanism and preclinical tissue-distribution studies have shown that it concentrates most heavily in adipose tissue and in the liver. In a Phase 1 Part 3B interim analysis at Day 109, DA-1726 demonstrated a 13.5% placebo-adjusted reduction in body weight, a 68.1% placebo-adjusted reduction in liver fat and a 0.24 percentage-point placebo-adjusted reduction in HbA1c, along with reductions in visceral and subcutaneous adipose tissue and relatively preserved lean mass. MetaVia is planning a Phase 2, 48-week, non-biopsy study of DA-1726 in MetALD and ALD, targeted to begin in the second half of 2027.

About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming liver-related cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of various cardiometabolic conditions, with potential in both Metabolic and Alcohol-Associated Liver Disease (MetALD) and Alcohol-Associated Liver Disease (ALD), and is advancing vanoglipel (DA-1241) in combination with resmetirom for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, engineered with a 3:1 GLP1R:GCGR potency ratio. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure. In a Phase 1 Part 3B interim analysis at Day 109, DA-1726 demonstrated placebo-adjusted reductions of 13.5% in body weight, 68.1% in liver fat and 0.24 percentage points in HbA1c, along with reductions in visceral and subcutaneous adipose tissue and relatively preserved lean mass. A Phase 2, 48-week, non-biopsy study of DA-1726 in MetALD and ALD, is targeted to begin in the second half of 2027. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). It acts directly in the liver on pathways involved in steatosis, inflammation and fibrosis, while GPR119 activation in the pancreas and gut also supports glucose and metabolic regulation. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. MetaVia is advancing vanoglipel in combination with resmetirom as a once-daily oral combination therapy for MASH, with a Phase 2a proof-of-concept study targeted to begin in the first half of 2027.

For more information, please visit www.metaviatx.com.

Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to obtain, maintain, protect and/or enforce sufficient intellectual property rights to execute its commercial strategy; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of preclinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@metaviatx.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

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SOURCE MetaVia Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did DA-1726 reduce uric acid in MetaVia's Phase 1 Part 3B trial?

DA-1726 produced a 1.47 mg/dL placebo-adjusted reduction after 16 weeks (p<0.001; 95% confidence interval: −2.0 to −0.9). At Day 109, treated participants had a 1.02 mg/dL decline from a 5.89 mg/dL baseline, while placebo participants had a 0.45 mg/dL increase from a 4.80 mg/dL baseline.

When does MetaVia plan to start the DA-1726 Phase 2 liver disease study?

MetaVia targets the second half of 2027 for a 48-week, non-biopsy Phase 2 study in up to 150 subjects. The planned study covers metabolic and alcohol-associated liver disease (MetALD) and alcohol-associated liver disease (ALD).

What DA-1726 dosing schedule did MetaVia use in Phase 1 Part 3B?

Participants receiving DA-1726 started at 16 mg for 4 weeks, increased to 32 mg for 4 weeks, and then reached the target dose of 64 mg. Treatment was administered once weekly by injection under the skin in the 16-week, randomized, placebo-controlled study.