Vanoglipel

All Active Patients in Both Cohorts Have Successfully Reached Highest Target Doses of 48 mg and 64 mg Topline Data Remains on Track for Fourth Quarter 2026 CAMBRIDGE, Mass., July 9, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that all enrolled active patients in Part 3 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity have successfully completed dose titration and are now receiving their highest target doses in both study cohorts. DA-1726 is a novel oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors. Part 3 of the Phase 1 program consists of two 16-week titration cohorts designed to evaluate one-step and two-step dose-escalation strategies to safely achieve higher target doses and further optimize tolerability. In Part 3A, patients titrated from 16 mg to 48 mg, while in Part 3B, patients titrated from 16 mg to 32 mg and subsequently to 64 mg. "The successful completion of dose titration across both Part 3 cohorts represents an important milestone for the DA-1726 development program," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Reaching our highest planned dose levels in all active patients reinforces the favorable tolerability profile of DA-1726. We believe our efficient titration strategy could represent a meaningful competitive advantage over currently marketed obesity therapies." Mr. Kim continued, "The robust data from our previously reported Phase 1 MAD study, including 9.1% mean weight loss achieved at the 48 mg dose in just 8 weeks of treatment, meaningful reductions in waist circumference, improved glycemic measures, and early signs of direct liver benefit, continue to demonstrate the differentiated potential of our dual GLP-1/glucagon mechanism. With all patients now on their target doses, we remain focused on completing treatment and reporting topline data in the fourth quarter of 2026." The Phase 1 Part 3 trial has a planned enrollment of approximately 40 obese, otherwise healthy adult subjects, across two parts, with approximately 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726. Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI), and other cardiometabolic measures. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel 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 preclinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in preclinical 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 GLP-1 receptor agonists such as semaglutide. 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 potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose and lipid control, and also proved differentiated hepatic benefits reducing hepatic steatosis, hepatic inflammation, and liver fibrosis regardless independent of metabolic improvement. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . 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 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 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE MetaVia Inc. 21% more press release views with Request a Demo

DA-1726 Phase 1, 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Vanoglipel Combined with Resmetirom Demonstrated Synergistic Hepatoprotective and Weight-Loss Effects in Preclinical MASH Model Vanoglipel Combined with Metformin Demonstrated Enhanced Glycemic Control and Body Weight Reduction Versus Monotherapy in a Preclinical T2D Model CAMBRIDGE, Mass., June 8, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new late-breaking data highlighting its obesity and metabolic disease portfolio at the American Diabetes Association's (ADA) 2026 Scientific Sessions, held June 5–8 in New Orleans, Louisiana. The presentations included new Phase 1 higher-dose cohort results for DA-1726, a novel dual agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), as well as preclinical data supporting combination treatment potential for vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, in metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2D) and obesity. The data highlighted favorable safety, tolerability and clinically meaningful reductions in body weight and waist circumference for DA-1726 at the 48 mg dose level, while the vanoglipel presentations demonstrated synergistic metabolic, liver-related effects and weight loss when combined with current standards of care, supporting potential combination strategies across MASH, T2D and obesity. "The late-breaking ADA 2026 data further reinforces the differentiated and complementary potential of our cardiometabolic pipeline," said Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 demonstrated clinically meaningful and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, along with consistent reductions in waist circumference and BMI in a once-weekly regimen without titration. Importantly, the data also demonstrates a sustained and progressive metabolic effect through Day 54, supporting continued advancement of higher-dose evaluation in our ongoing Phase 1 Part 3 titration studies designed to assess higher-dose exposure and durability of metabolic response, with results expected in the fourth quarter of 2026." "In parallel, preclinical vanoglipel combination data demonstrated synergistic effects across liver and metabolic disease models, including meaningful improvements in hepatic steatosis, liver injury markers, fibrosis-related biomarkers, glycemic control, and body weight. Importantly, when combined with resmetirom, vanoglipel's ability to unlock synergistic benefits highlights its potential as a combination strategy for MASH. In addition, when combined with metformin, vanoglipel improved glycemic control and reduced body weight to a greater extent than either monotherapy, further supporting its potential as a therapeutic combination strategy for additional metabolic benefit in T2D. Taken together, these findings further support DA-1726 as a differentiated obesity therapy and vanoglipel as a versatile metabolic backbone for combination approaches in MASH and type 2 diabetes." Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort Results Presenting Author: Weikai "Chris" Fang, Chief Medical Officer, MetaVia Abstract Control Number: 3102-LB Session: 23-B Obesity—Human The late-breaking poster presentation of DA-1726 reported interim results from a randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose study evaluating once-weekly subcutaneous administration in obese but otherwise healthy adults. In the 48 mg cohort, DA-1726 was generally well tolerated, with predominantly mild-to-moderate and transient gastrointestinal adverse events and no treatment-related discontinuations or serious adverse events. Pharmacokinetic (PK) analysis demonstrated sustained exposure with dose-proportional behavior. DA-1726 produced a 6.1% reduction in body weight at Day 26 and a 9.1% reduction at Day 54 (p<0.05 vs placebo at Day 26), with continued reductions through Week 8 and no evidence of plateau. Waist circumference was reduced by 5.8 cm at Day 22 and 9.8 cm at Day 54 (p<0.05 vs placebo), with accompanying reductions in BMI of 2.3 kg/m² and 3.4 kg/m² at Day 22 and Day 54, respectively. These clinically meaningful, statistically significant body weight reductions at higher doses were consistent with the dose-proportional PK profile and support continued development for obesity. Title: Synergistic Hepatoprotective and Weight-Loss Effects of Vanoglipel and Resmetirom Combination Therapy in a Diet-Induced Obese, Biopsy-Confirmed Mouse Model of MASH Presenting Author: Yuna Chae, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 3043-LB Session: 22-C Integrated Physiology—Liver The late-breaking preclinical study evaluating vanoglipel in combination with resmetirom demonstrated synergistic hepatoprotective and weight-loss effects in a biopsy-confirmed diet-induced obese mouse model of MASH. While monotherapies had no significant effect on body weight, combination treatment achieved a 23.6% reduction versus control (p<0.05), with endpoint fat mass and epididymal fat weight reduced by 43.5% and 42.1%, respectively. All treatments decreased ALT, with the largest reduction rate of 83.5% in the combination group. Histopathologic assessment showed significant improvements in hepatic lipid accumulation, inflammation and fibrosis-related biomarkers. The study represents the first demonstration of the therapeutic potential of combined targeting of GPR119 and thyroid hormone receptor beta (THRβ) for MASH. Title: Synergistic Effects of Vanoglipel and Metformin on Glycemic Control and Body Weight Reduction in a Diet-Induced Obese Mouse Model Presenting Author: Tae Hyoung Kim, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 2856-LB Session: 12-D Clinical Therapeutics—Other Therapeutic Agents The late-breaking preclinical study evaluating vanoglipel in combination with metformin demonstrated greater metabolic and weight effects than either monotherapy in a diet-induced obese mouse model with mild hyperglycemia. Combination treatment reduced non-fasting glucose by 28.7% (p<0.05) and fasting glucose by 22.7% versus control. While each monotherapy reduced body weight by approximately 4%, the combination achieved a 16.3% reduction versus control (p<0.05). Fat mass increased by 0.4-1.4 g from baseline in the control and monotherapy groups but decreased by 3.6 g in the combination group (-25.6% vs baseline, p<0.05). These effects were accompanied by increases in total GLP-1 and peptide YY (PYY) levels of 6.4-fold and 1.5-fold, respectively, along with reduced food intake, supporting enhanced gut hormone–mediated metabolic activity. A copy of the posters will be available on the Posters section of the MetaVia website after the presentation. About DA-1726 DA-1726 is a novel 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 preclinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in preclinical 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 Vanoglipel (DA-1241) Vanoglipel is a once daily, orally available G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the pancreas stimulates glucose-dependent insulin secretion, and in the gut, it promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver pathology including steatosis, inflammation and fibrosis, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a and 1b trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. 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 GLP-1 receptor agonists such as semaglutide. 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 potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose and lipid control, and also proved differentiated hepatic benefits reducing hepatic steatosis, hepatic inflammation, and liver fibrosis regardless independent of metabolic improvement. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . 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 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 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com SOURCE MetaVia Inc. 21% more press release views with Request a Demo