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Noticias de MTVA
Eventos de MTVA
MetaVia Successfully Completes Dose Titration for DA-1726 Clinical Trial
MetaVia 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 analog targeting both GLP-1 and glucagon 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."
MetaVia Presents New Phase 1 Data on DA-1726, Weight Loss of 9.1%
MetaVia announced the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin - OXM - analog agonist targeting glucagon-like peptide-1 receptors, or GLP1R, and glucagon receptors, or GCGR, at the European Association for the Study of the Liver Congress 2026 held May 27-30 in Barcelona. The data highlighted favorable safety and tolerability, clinically meaningful reductions in body weight and waist circumference at the 48 mg dose without titration, and exploratory, noninvasive liver-related findings supporting continued evaluation in metabolic dysfunction-associated steatohepatitis, or MASH. DA-1726 demonstrated progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, while maintaining favorable tolerability even in the absence of dose titration. Exploratory FibroScan findings demonstrated early and consistent improvements across multiple noninvasive liver biomarkers, including liver stiffness, CAP and FAST scores, illustrating the potential of DA-1726 in obesity and MASH, where metabolic and hepatic dysfunction are closely linked. Based on these findings, MetaVia continues to advance the ongoing Phase 1 Part 3a/3b titration studies designed to evaluate longer-term dosing strategies, optimize tolerability at higher exposures, and further assess durability of metabolic and liver-related effects. DA-1726 was generally well tolerated up to the 48 mg dose level, with no serious adverse events or treatment-related discontinuations observed. No clinically meaningful changes in cardiovascular parameters were observed. Participants achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54, with no evidence of a plateau through Week 8. Waist circumference was reduced by 5.8 cm at Day 26 and 9.8 cm at Day 54. Liver-related improvements support further long-term evaluation of DA-1726 in obesity-associated liver disease and MASH.
MetaVia Begins Phase 1 Part 3 Clinical Trial for DA-1726
MetaVia announced that the first patient has been dosed in Part 3 of its Phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin analog targeting both GLP-1 and glucagon 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.
MetaVia CEO: DA-1726 Shows Significant Weight Loss Results
"We made significant progress advancing our cardiometabolic portfolio during the year, punctuated by the positive data, released in January of this year, from the Phase 1 extended 8-week, non-titrated 48 mg cohort of lead asset DA-1726, a novel, dual oxyntomodulin analog agonist that functions as a glucagon-like peptide-1 receptor and glucagon receptor, for the treatment of obesity and related metabolic disorders," stated Hyung Heon Kim, CEO of MetaVia. "These results demonstrated robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, all achieved without titration and with a favorable safety and tolerability profile. We believe this combination of weight loss, glycemic control, direct hepatic benefit and tolerability meaningfully differentiates DA-1726 and supports its potential to deliver a best-in-class profile in obesity and broader cardiometabolic disease. Importantly, DA-1726 is supported by a growing intellectual property estate comprising 39 granted and pending patents in the United States and internationally, providing protection at least through 2041. On the heels of the positive Phase 1 data, we strengthened our balance sheet in January with gross proceeds of $9.3 million from an underwritten public offering, providing additional capital to advance the DA-1726 program. Having recently received Institutional Review Board approval from the Clinical Pharmacology of Miami, we expect to initiate dosing in our Phase 1 Part 3, 16-week titration studies evaluating escalation to 48 mg in a single step and 64 mg using a two-step regimen in April, with data anticipated in the fourth quarter of 2026." Kim continued, "Beyond DA-1726, we continued to advance vanoglipel, a novel G-Protein-Coupled Receptor 119 agonist, with the presentation of positive Phase 2a data at the American Association for the Study of Liver Diseases The Liver Meeting 2025, highlighting clinically meaningful improvements in glucose control, liver health and plasma lipidomic profiles over 16 weeks. In parallel, results from our collaboration with Syntekabio using the DeepMatcher artificial intelligence platform confirmed strong inflammatory and cardiometabolic target engagement, further supporting development of vanoglipel in MASH and, potentially, in type 2 diabetes. We believe both programs position MetaVia at the forefront of next-generation cardiometabolic innovation as we move into 2026."
MetaVia Receives Approval for DA-1726 Clinical Trial
MetaVia announced that the Institutional Review Board, IRB, at Clinical Pharmacology of Miami has approved the Company's Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog targeting both GLP-1 and glucagon receptors. The approval enables initiation of Part 3 of the Phase 1 program, which consists of two 16-week titration cohorts evaluating one-step and two-step dose-escalation strategies intended to safely reach higher target doses and further optimize tolerability.
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