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New Phase 1 PK Data Support Once-Weekly Dosing; Clinically Meaningful Weight Loss Observed Without Dose Titration
DA-1726 Achieves Superior Lipid-Lowering Effects and Comparable Weight Loss to Pemvidutide in Pre-clinical Models
CAMBRIDGE, Mass., Nov. 4, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it will present new Phase 1 and pre-clinical data on DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), in two poster presentations at ObesityWeek® 2025, taking place in-person and virtually November 4-7, 2025 in Atlanta, GA. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy.
"These Phase 1 results continue to reinforce DA-1726's potential as a differentiated dual agonist for the treatment of obesity," said Hyung Heon Kim, Chief Executive Officer of MetaVia. "The favorable safety profile observed, even without titration, together with potentially best-in-class early weight loss, waist circumference reduction and clean cardiovascular findings, is highly encouraging. The newly reported PK data demonstrating linear, dose-proportional exposure and an approximate 80-hour half-life, further support the convenience and consistency of once-weekly dosing. Based on these results, we have extended the Phase 1 study to a 48 mg dose for a total of 8 weeks to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose. We expect to read out the results from the 48 mg cohort later this year."
At the highest tested dose of 32 mg, presented in the poster, participants achieved a body-weight reduction of up to 6.3% from baseline, with an average reduction of 4.3% at Day 26. Waist circumference decreased by as much as 3.9 inches, with effects sustained for two weeks after dosing ended.
The 32 mg PK data, presented for the first time, shows linear, dose-proportional exposure and a mean half-life of approximately 80 hours, confirming the feasibility of once-weekly dosing.
DA-1726 was well tolerated across all dose levels, with no serious adverse events or treatment discontinuations. Reported gastrointestinal events were mild and transient, and no clinically meaningful changes were observed in cardiovascular parameters, including heart rate or QTcF interval.
The Phase 1 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45 kg/m². Each of the 4 cohorts presented in the poster included nine participants randomized 6:3 to receive four once-weekly subcutaneous doses of DA-1726 or placebo. The primary objective was to assess safety and tolerability based on adverse events (AEs), serious adverse events (SAEs), treatment-emergent events (TAEs), and discontinuations. Secondary endpoints evaluated PK parameters, including serum concentration and metabolite profiling at higher doses, while exploratory assessments measured metabolic, cardiovascular, and lipid parameters, as well as changes in body weight, waist circumference, and BMI.
For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.
Presentation Details:
Mr. Kim added "The pre-clinical data presented highlighted the differentiated metabolic profile of DA-1726 compared with other dual agonists. DA-1726 demonstrated comparable weight-loss efficacy to pemvidutide while delivering superior lipid-lowering effects, including greater reductions in total cholesterol and LDL-C. In addition, DA-1726 produced greater weight loss than tirzepatide despite similar food intake, driven by enhanced energy expenditure not associated with increased physical activity. These findings support DA-1726's potential to deliver broader and more durable metabolic benefits for patients with obesity."
In preclinical studies, DA-1726 promoted weight reduction by suppressing appetite and increasing energy expenditure in DIO mice. Comparative analyses focused on energy expenditure relative to tirzepatide and on body composition relative to pemvidutide, along with assessments of body weight and lipid metabolism in both treatment groups.
Compared to tirzepatide, DA-1726 produced greater weight loss despite similar food intake, accompanied by enhanced energy expenditure not attributable to increased locomotor activity. DA-1726 also led to greater reductions in total cholesterol (T-CHO) and LDL-C, demonstrating a distinct glucagon-mediated metabolic mechanism.
When compared with pemvidutide, DA-1726 achieved similar body-weight reductions and improvements in body composition, including decreased fat mass and relatively preserved lean mass. Notably, DA-1726 delivered superior lipid-lowering benefits, showing greater reductions in total cholesterol, LDL-C, and triglycerides across treatment groups.
Presentation Details:
A copy of the posters are available on the Posters section of the MetaVia website.
About DA-1726
DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. 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. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction.
About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) 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. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit www.metaviatx.com.
Contacts:
MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
[email protected]
Rx Communications Group
Michael Miller
+1-917-633-6086
[email protected]
SOURCE MetaVia Inc.
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