First Patient Dosed in DA-1726 Phase 1 Trial for Obesity Treatment

CAMBRIDGE, Mass., June 26, 2024. NeuroBo Pharmaceuticals, Inc., a biotechnology firm focusing on innovative treatments for cardiometabolic disorders, has announced the commencement of dosing for the first patient in the multiple ascending dose (MAD) segment of its Phase 1 clinical trial for DA-1726. DA-1726 is a novel dual oxyntomodulin (OXM) analog agonist, combining actions on both glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), aimed at treating obesity.

Hyung Heon Kim, President and CEO of NeuroBo, emphasized the significance, stating, "The early dosing of the first patient in this segment, ahead of schedule, highlights our dedication to rapidly advancing DA-1726, which we believe could become a highly differentiated obesity treatment." In preclinical mouse models, DA-1726 demonstrated superior weight loss compared to semaglutide (Wegovy®) and showed similar weight reduction while allowing greater food intake compared to tirzepatide (Zepbound®). Moreover, during presentations at the American Diabetes Association's 84th Scientific Sessions, DA-1726 exhibited better weight loss and lean body mass preservation versus survodutide, another drug with a similar mechanism, along with superior glucose-lowering effects.

NeuroBo anticipates that DA-1726 could potentially set itself apart as a best-in-class obesity treatment due to its balanced activation of GLP1R and GCGR, which might offer a better tolerability profile than current GLP-1 agonists. Both segments of the Phase 1 trial are progressing well, with top-line data from the single ascending dose (SAD) Part 1 expected in the third quarter of this year, and results from the MAD Part 2 in the first quarter of 2025.

Following a successful financing event yielding up to $70 million, with $20 million upfront and $50 million tied to clinical milestones, NeuroBo is well-equipped to advance DA-1726 through its upcoming milestones. This funding will support a planned multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 trial. Scheduled to commence after the completion of Part 2, Part 3 will investigate several parameters over 24 weeks, including total weight loss, dietary changes, weight loss through fat or lean muscle reduction, maximum-tolerated doses, and other exploratory endpoints. The trial's design aims to position DA-1726 as a leading dual agonist for obesity treatment.

The current Phase 1 trial follows a randomized, placebo-controlled, double-blind, two-part format to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy subjects. The SAD study in Part 1 is enrolling approximately 45 participants divided into five cohorts, each randomized in a 6:3 ratio to receive either DA-1726 or a placebo. Part 2, the MAD study, aims to enroll around 36 participants, also randomized in a 6:3 ratio across four cohorts to receive four weekly doses of either DA-1726 or a placebo.

The primary goal of the trial is to evaluate the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and discontinuations due to AEs. Secondary endpoints include the PK profile of DA-1726 through serum concentration measurements and metabolite profiling at the highest doses. Exploratory endpoints will assess DA-1726's impact on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI).

DA-1726, administered subcutaneously once weekly, acts as a dual agonist of GLP-1 and glucagon receptors, facilitating weight loss via reduced appetite and increased energy expenditure. In preclinical studies, it showed improved weight loss compared to semaglutide and cotadutide, while also allowing greater food intake and preserving lean body mass compared to tirzepatide and survodutide.

NeuroBo Pharmaceuticals, Inc. is dedicated to transforming cardiometabolic disease treatments. They also have another promising candidate, DA-1241, an agonist targeting G-protein-coupled receptor 119 (GPR119) for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH). Preclinical studies on DA-1241 have shown promising results in reducing liver inflammation, improving lipid metabolism and glucose control.