Enrollment Finished for Phase 1 SAD Trial of DA-1726 for Obesity Treatment

NeuroBo Pharmaceuticals, Inc., a biotech firm concentrated on revolutionizing cardiometabolic diseases, has reached a significant milestone with the completion of enrollment for the single ascending dose (SAD) Phase 1 clinical trial of its innovative drug, DA-1726. This trial aims to evaluate the drug’s efficacy in treating obesity. The study enrolled 45 participants who were randomly assigned into one of five cohorts, with a 6:3 ratio of DA-1726 to placebo.

Hyung Heon Kim, the President and CEO of NeuroBo, highlighted the importance of this milestone, emphasizing the company's dedication to advancing treatments for cardiometabolic diseases. Kim noted that the SAD study progressed without major issues, allowing the team to transition ahead of schedule into the multiple ascending dose (MAD) study. Pre-clinical data had already indicated that DA-1726 could deliver superior weight loss compared to existing drugs like semaglutide (Wegovy®) and tirzepatide (Zepbound®). These findings were presented at the American Diabetes Association’s 84th Scientific Sessions, showing DA-1726's potential to outperform survodutide, a drug with a similar mechanism, in terms of weight loss and glucose management.

Kim also shared timelines for the ongoing program. The top-line data from the SAD Part 1 is expected in the third quarter of this year, with data from MAD Part 2 anticipated in the first quarter of 2025. The company also plans to begin Part 3 of the trial in the third quarter of 2025, pending approval from the U.S. Food and Drug Administration (FDA).

The Phase 1 trial is structured as a randomized, placebo-controlled, double-blind study, aimed at assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726 when administered in single and multiple doses. Part 2, which is currently enrolling participants, will involve approximately 36 subjects, who will be randomized at a 6:3 ratio into four cohorts. These participants will receive four weekly doses of either DA-1726 or a placebo. The first participant in the MAD study received their dosage earlier than planned, in late June.

The trial’s primary endpoint focuses on the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and any AEs leading to discontinuation of treatment. Secondary endpoints include evaluating the pharmacokinetics of DA-1726 through serum concentration measurements and metabolite profiling at higher doses. Exploratory endpoints will study the drug's impact on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI) among other factors.

DA-1726 is a novel oxyntomodulin (OXM) analogue designed as a dual agonist for GLP1R and GCGR, aimed at treating obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The drug is administered once weekly via subcutaneous injection and has demonstrated promising results in pre-clinical mouse models, offering better weight loss outcomes compared to other drugs like semaglutide and cotadutide. It also showed improved lipid-lowering effects and lean body mass preservation compared to survodutide.

NeuroBo Pharmaceuticals, Inc., is devoted to addressing cardiometabolic diseases through innovative therapies. In addition to DA-1726, the company is developing DA-1241 for treating MASH. This novel G-protein-coupled receptor 119 (GPR119) agonist has shown positive effects in pre-clinical studies on liver inflammation, lipid metabolism, weight loss, and glucose control, indicating its potential for broader therapeutic applications.