DA-1726 / Dong-A - LARVOL DELTA

MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose (PRNewswire) - "MetaVia...announced dosing of the first patient in the 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. Top-line data is expected in the fourth quarter of 2025."

P1 data • Trial status • Obesity

Dong-A ST develops monthly obesity injection DA-1726 with global expansion in sight (Chosun Biz) - "Dong-A ST is currently conducting global clinical trials for the obesity treatment candidate 'DA-1726' through its subsidiary Metabia, aiming for U.S. sales approval by 2030."

FDA approval • Obesity

DA-1726-1001: First in Human Study in Subjects With Obesity, But Otherwise Healthy (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: NeuroBo Pharmaceuticals Inc. | Trial completion date: Jun 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential (PRNewswire) - P1 | N=81 | NCT06252220 | Sponsor: NeuroBo Pharmaceuticals Inc. | "MetaVia Inc....today reported additional top-line results from the multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726....In the 28-day, 36-subject MAD portion of the study, a clear dose-responsive trend in body weight (BW) reduction was observed across the 8 mg to 32 mg range, indicating potentially greater efficacy at higher doses and longer duration of use. Additionally, body mass index (BMI), which shows body weight adjusted for height, showed a difference between the treatment group and the placebo (PBO) group, which was even more pronounced, further supporting the dose-dependent effect of the drug on weight-related outcomes....There were no treatment-related discontinuations or SAEs. Early satiety was observed in 83% of subjects receiving the 32 mg dose, suggesting the potential for greater weight loss with longer treatment duration."

P1 data • Obesity

MetaVia Announces Positive Top-Line Data From the 4-Week Phase 1 MAD Trial of DA-1726, a Novel 3:1 Ratio GLP-1 Glucagon Dual Receptor Agonist to Treat Obesity, Showing Compelling Weight Loss and Safety Effects With Potential Best-In-Class Glucose Control (GLP-1R), Waist Reduction (GCGR), and Tolerability (PRNewswire) - P1 | N=81 | NCT06252220 | Sponsor: NeuroBo Pharmaceuticals Inc. | "MetaVia Inc...announced positive results from the 4-week multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity....'The data also indicates strong clinical characteristics, with compelling tolerability and a maximum weight loss of -6.3% at the 32 mg dose, which is not yet the maximum tolerated dose, along with a mean weight reduction of -4.3% from baseline. Although subjects in this study were exposed to study drug or placebo for a total of 26 days, no signs of plateau were observed. Given GLP-1R lowers glucose levels while GCGR increases them, the 3:1 ratio of DA-1726 may provide an optimal balance to achieve a sustainable and tolerable therapeutic effect in this class of drugs."

P1 data • Obesity

MetaVia Reports Year End 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Anticipated Clinical Milestones: DA-1726 in Obesity: Top-line data from the additional cohorts in the MAD Part 2 is expected in April of 2025. The planned Phase 1 Part 3 will evaluate early proof of concept, with the first patient expected to be enrolled during the fourth quarter of 2025, followed by an interim data readout in or around mid-2026 and top-line results are expected in the second half of 2026. DA-1241 in MASH: The full data set from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected to be presented at a major medical meeting in 2025. The Company expects to have an end-of-Phase 2 meeting with the FDA in the first half of 2025."

Enrollment status • FDA event • P1 data • P2a data • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

…Hanmi Pharmaceuticals to conduct phase 3 new drug trial [Google translation] (Nate) - "In addition to Hanmi Pharmaceutical, HK inno.N...submitted a phase 3 clinical trial plan for its obesity drug candidate 'IN-B00009' to the Ministry of Food and Drug Safety at the end of last year. It plans to start clinical trials next month and complete them in early 2028....Dong-A ST (170900), is conducting phase 1 clinical trials for its obesity drug 'DA-1726'. It plans to release the first clinical results in the third quarter of this year."

New P3 trial • P1 data • Trial completion date • Obesity

NeuroBo Pharmaceuticals Announces Strategic Realignment Ahead of Important Clinical Milestones with Name Change to MetaVia - Reflecting the Company's Focus on Cardiometabolic Diseases (PRNewswire) - "NeuroBo Pharmaceuticals, Inc...today announced a strategic realignment, ahead of important clinical milestones, with a corporate name change to 'MetaVia Inc.,' which will be effective on November 29, 2024...In parallel, the Company's common stock will begin trading on the Nasdaq Stock Market under the new ticker symbol, 'MTVA,' which is expected to be operative as of the Effective Date. As part of its corporate name change, the company will also launch a new website, metaviatx.com, and a new company logo, on the Effective Date."

Commercial • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

DA-1726, a GLP1R/GCGR Dual Agonist, a Promising Approach in Obesity Treatment and Lipid Management (ADA 2024) - "In a prior study, DA-1726 showed a difference in improving lipid levels, despite similar weight loss to tirzepatide...In an obese mouse model, DA-1726 significantly lowered T-CHO (-67.7%, -49.6%; P<0.05 vs. control) and TG (-49.5%, -41.2%; P<0.05 vs. control) levels under conditions that resulted in similar weight loss effects (-31.9%, -25.4%; P<0.05 vs. control) as survodutide...DA-1726's glucagon action could further enhance energy expenditure (EE), and it is believed to have significantly increased the expression of EE-related genes in brown adipose tissue. In summary, it was confirmed that DA-1726 has differentiating characteristics in the competition of obesity treatment drugs with similar or identical mechanisms in its effect on improving cholesterol metabolism through glucagon action."

Late-breaking abstract • Metabolic Disorders • Obesity

NeuroBo Pharmaceuticals’ DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass, and Lipid-Lowering Effects Compared to Survodutide, in Pre-Clinical Models (PRNewswire) - "NeuroBo Pharmaceuticals...today announced pre-clinical data which indicates that DA-1726...demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to survodutide, in pre-clinical models....'DA-1726, in obese mouse models, significantly lowered cholesterol levels and induced superior weight loss, compared to survodutide, a drug with the same mechanism of action, while also exhibiting superior glucose lowering. Most notably, DA-1726 demonstrated superior weight loss and retention of relative lean body mass preservation compared to survodutide.'"

Preclinical • Metabolic Disorders • Obesity

NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update (PRNewswire) - "DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024. Initiation of the multiple ascending dose (MAD) study Part 2 is expected in the third quarter of 2024 and the top-line data expected in the first quarter of 2025. DA-1241 in MASH: Full enrollment of the two-part Phase 2a clinical trial of DA-1241 in MASH is expected in the third quarter of 2024. Top-line results are expected to be available in the fourth quarter of 2024."

Enrollment status • P1 data • P2a data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

DA-1726-1001: First in Human Study in Subjects With Obesity, But Otherwise Healthy (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: NeuroBo Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity (PRNewswire) - "NeuroBo Pharmaceuticals, Inc....announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity....'Notably, we have significantly accelerated the timelines for the Phase 1 trial, and look forward to dosing the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year. Additionally, we now expect to report top-line data from the SAD Part 1 in the third quarter of 2024, and the MAD Part 2 in the first quarter of 2025.'"

P1 data • Trial status • Metabolic Disorders • Obesity

NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity (PRNewswire) - "NeuroBo Pharmaceuticals, Inc...today announced that it has received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah, FL, to proceed with the Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The company expects to randomize the first patient in the second quarter of this year....The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part 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."

Trial status • Metabolic Disorders • Obesity

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity (PRNewswire) - "NeuroBo Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year....The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, sequential parallel group 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."

IND • New P1 trial • Metabolic Disorders • Obesity

First in Human Study in Subjects With Obesity, But Otherwise Healthy (clinicaltrials.gov) - P1 | N=81 | Not yet recruiting | Sponsor: NeuroBo Pharmaceuticals Inc.

New P1 trial • Genetic Disorders • Obesity

NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity (PRNewswire) - "NeuroBo Pharmaceuticals, Inc...today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity...'We look forward to initiating the clinical development for DA-1726, with the first dose expected to be administered in the first half of 2024 and an expected data readout in the first half of 2025.'....The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, sequential parallel group 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. Part 1 will be a single ascending dose (SAD) study..."

IND • New P1 trial • P1 data • Metabolic Disorders • Obesity

“Dong-A ST approves Stelara similar in the second half of next year and announces phase 1 results for NASH and obesity treatment” [Google translation] (Insight Korea) - "'In addition, there is a lot of momentum in the second half of 2024, with the approval of Stelara biosimilar DA-3115, announcement of phase 1 results for NASH treatment DA-1241, and phase 1 interim results for obesity treatment DA-1726. Once the obesity treatment DA-1726 completes Phase 1a in the first half of next year, it is expected to enter Phase 1b/2a and confirm efficacy in 20’5 before technology transfer...'"

BLA • New P1/2 trial • P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Obesity • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis