MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity to 8 Weeks and Announces Fifth Weekly Dose in First Patient
MetaVia (NASDAQ:MTVA) has announced the extension of its Phase 1 clinical trial's 48 mg multiple ascending dose (MAD) cohort for DA-1726, its novel obesity treatment, from 4 to 8 weeks. The company has successfully administered the fifth weekly dose to the first patient.
The extension aims to evaluate longer-term early efficacy, safety, and explore the non-titrated maximum tolerated dose. Previously reported data from the 32 mg dose showed promising results, including mean weight loss of 4.3% (max 6.3%) by Day 26, early satiety in 83% of patients, and waist reductions up to 3.9 inches by Day 33.
DA-1726, a dual oxyntomodulin analog agonist, features a 3:1 balanced activation of GLP-1 and glucagon receptors, potentially offering better tolerability compared to current GLP-1 therapies. Top-line data from the extended trial is expected in Q4 2025.
MetaVia (NASDAQ:MTVA) ha annunciato l'estensione del coorte da 48 mg a dosi multiple ascendenti (MAD) della sua sperimentazione clinica di Fase 1 per DA-1726, il suo nuovo trattamento per l'obesit脿, da 4 a 8 settimane. La societ脿 ha somministrato con successo la quinta dose settimanale al primo paziente.
L'estensione mira a valutare l'efficacia precoce a lungo termine, la sicurezza e a esplorare la dose massima tollerata senza titolazione. I dati precedentemente riportati dalla dose da 32 mg hanno mostrato risultati promettenti, inclusa una perdita di peso media del 4,3% (massimo 6,3%) al giorno 26, saziet脿 precoce nell'83% dei pazienti e riduzioni della circonferenza vita fino a 9,9 cm al giorno 33.
DA-1726, un agonista analogo duale dell'oxyntomodulina, presenta una attivazione bilanciata 3:1 dei recettori GLP-1 e glucagone, offrendo potenzialmente una migliore tollerabilit脿 rispetto alle terapie GLP-1 attuali. I dati principali della sperimentazione estesa sono attesi nel quarto trimestre 2025.
MetaVia (NASDAQ:MTVA) ha anunciado la extensi贸n del cohorte de dosis m煤ltiples ascendentes (MAD) de 48 mg en su ensayo cl铆nico de Fase 1 para DA-1726, su nuevo tratamiento contra la obesidad, de 4 a 8 semanas. La compa帽铆a ha administrado con 茅xito la quinta dosis semanal al primer paciente.
La extensi贸n tiene como objetivo evaluar la eficacia temprana a largo plazo, la seguridad y explorar la dosis m谩xima tolerada sin titulaci贸n. Los datos previamente reportados de la dosis de 32 mg mostraron resultados prometedores, incluyendo una p茅rdida de peso media del 4,3% (m谩ximo 6,3%) al d铆a 26, saciedad temprana en el 83% de los pacientes y reducciones de cintura de hasta 9,9 cm al d铆a 33.
DA-1726, un agonista an谩logo dual de la oxintomodulina, presenta una activaci贸n equilibrada 3:1 de los receptores GLP-1 y glucag贸n, ofreciendo potencialmente una mejor tolerabilidad en comparaci贸n con las terapias actuales de GLP-1. Se esperan los datos principales del ensayo extendido en el cuarto trimestre de 2025.
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MetaVia (NASDAQ:MTVA) a annonc茅 la prolongation de la cohorte de doses multiples ascendantes (MAD) de 48 mg de son essai clinique de phase 1 pour DA-1726, son nouveau traitement contre l'ob茅sit茅, de 4 脿 8 semaines. La soci茅t茅 a administr茅 avec succ猫s la cinqui猫me dose hebdomadaire au premier patient.
Cette prolongation vise 脿 茅valuer l'efficacit茅 pr茅coce 脿 plus long terme, la s茅curit茅 et 脿 explorer la dose maximale tol茅r茅e non titr茅e. Les donn茅es pr茅c茅demment rapport茅es pour la dose de 32 mg ont montr茅 des r茅sultats prometteurs, notamment une perte de poids moyenne de 4,3% (maximum 6,3%) au jour 26, une sati茅t茅 pr茅coce chez 83% des patients et des r茅ductions de tour de taille allant jusqu'脿 9,9 cm au jour 33.
DA-1726, un agoniste analogue dual de l'oxyntomoduline, pr茅sente une activation 茅quilibr茅e 3:1 des r茅cepteurs GLP-1 et glucagon, offrant potentiellement une meilleure tol茅rance par rapport aux th茅rapies GLP-1 actuelles. Les donn茅es principales de l'essai prolong茅 sont attendues au 4e trimestre 2025.
MetaVia (NASDAQ:MTVA) hat die Verl盲ngerung der 48 mg Multiple Ascending Dose (MAD) Kohorte seiner Phase-1-Studie f眉r DA-1726, seine neuartige Behandlung von Fettleibigkeit, von 4 auf 8 Wochen bekannt gegeben. Das Unternehmen hat die f眉nfte w枚chentliche Dosis beim ersten Patienten erfolgreich verabreicht.
Die Verl盲ngerung zielt darauf ab, die l盲ngerfristige fr眉he Wirksamkeit und Sicherheit zu bewerten sowie die nicht-titrierte maximal vertr盲gliche Dosis zu erforschen. Zuvor berichtete Daten der 32 mg-Dosis zeigten vielversprechende Ergebnisse, darunter einen durchschnittlichen Gewichtsverlust von 4,3% (maximal 6,3%) bis Tag 26, fr眉he S盲ttigung bei 83 % der Patienten und eine Taillenumfangsreduktion von bis zu 9,9 cm bis Tag 33.
DA-1726, ein dualer Oxyntomodulin-Analogon-Agonist, weist eine 3:1 ausgewogene Aktivierung der GLP-1- und Glukagon-Rezeptoren auf und k枚nnte eine bessere Vertr盲glichkeit im Vergleich zu aktuellen GLP-1-Therapien bieten. Die wichtigsten Daten der verl盲ngerten Studie werden f眉r das 4. Quartal 2025 erwartet.
- Strong weight loss effects demonstrated in 32 mg dose (4.3% mean, 6.3% maximum)
- Early satiety achieved in 83% of patients
- Significant waist reductions of up to 3.9 inches observed
- Favorable glycemic and cardiovascular safety profile
- Mild and transient GI profile suggesting better tolerability than existing treatments
- Extended trial duration may delay final results and potential commercialization
- Still in early Phase 1 stage, far from potential FDA approval
- Competition from established GLP-1 therapies in the market
Insights
MetaVia's Phase 1 trial extension for obesity drug DA-1726 aims to gather more robust data on potentially differentiated dual-receptor mechanism with promising early results.
MetaVia's decision to extend the high-dose (48 mg) cohort of its Phase 1 trial for DA-1726 from 4 to 8 weeks represents a strategic enhancement to their development program. This extension is designed to gather more comprehensive safety data and explore early efficacy signals over a longer duration鈥攁 critical step for obesity medications that require chronic administration.
The company's dual oxyntomodulin analog employs a 3:1 balanced activation ratio between GLP-1 and glucagon receptors, which could theoretically provide a mechanistic advantage over pure GLP-1 agonists. The preliminary data from the 32 mg cohort showing
The reported waist circumference reduction (up to 3.9 inches) and early satiety effects (in
The decision to proceed with a non-titrated approach is particularly interesting, as titration schedules with current GLP-1 therapies can extend 4-5 months, creating adherence challenges. A medication that achieves therapeutic doses faster with comparable efficacy and improved tolerability would have significant clinical advantages in the rapidly growing obesity market.
Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose
Top-Line Data Expected in the Fourth Quarter of 2025
"Extending DA-1726 administration by an additional 4 weeks鈥攆or a total of 8 weeks鈥攊n the 48 mg cohort represents a meaningful step forward as we seek to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "After reviewing the original trial design and previous results, we feel confident that the 4-week extension can potentially provide more robust data, which we believe may position DA-1726 more strongly against current treatments and those in late-stage clinical trials. By extending exposure to the drug, we aim to more fully evaluate DA-1726's therapeutic profile across primary, secondary and exploratory endpoints鈥攊ncluding safety, tolerability, body weight, waist circumference, and body mass index (BMI), among others鈥攁nd to further unlock its full therapeutic potential. Previously reported data from the 32 mg dose demonstrated strong weight loss effects (mean:
Mr. Kim added, "We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20鈥�
The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index (BMI) between 30 鈥� 45 kg/m2. Nine subjects in each cohort are randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort will add 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.
For more information on this clinical trial, please visit: NCT06252220.
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庐) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound庐) 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 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 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. DA-1241 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, DA-1241 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, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit .
Contacts:
MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
[email protected]
Michael Miller
+1-917-633-6086
[email protected]
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