NeuroBo Reports Positive Phase 1 Trial Results for Obesity Drug DA-1726

NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company, recently announced promising top-line data from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial for DA-1726, a novel dual oxyntomodulin (OXM) analog agonist. This drug targets obesity by functioning as both a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) agonist.

The SAD Part 1 of the Phase 1 trial involved 45 obese but otherwise healthy participants, who were randomly assigned in a double-blind manner to receive either DA-1726 or a placebo in a 6:3 ratio. The trial demonstrated that single ascending doses of DA-1726 were safe and well-tolerated, with no serious adverse events reported. Only five participants in the DA-1726 treatment group experienced adverse events, compared to three in the placebo group. Additionally, the trial revealed a dose-linear pharmacokinetics (PK) profile across the range of doses studied. NeuroBo is now adding additional cohorts to the SAD Part 1 to explore the maximum tolerated dose.

Hyung Heon Kim, President and CEO of NeuroBo, noted that the positive safety, tolerability, and dose-linear PK data from the SAD Part 1 have facilitated the accelerated start of the multiple ascending dose (MAD) study. He emphasized that the strong safety profile observed has encouraged the addition of more cohorts to fully understand DA-1726's potential. Based on preclinical data and the balanced activation of GLP1R and glucagon receptors, which boost energy expenditure, Kim expressed optimism that DA-1726 could surpass existing GLP-1 agonists in terms of tolerability and efficacy for obesity treatment. NeuroBo anticipates releasing top-line data from the MAD Part 2 study in the first quarter of 2025, which will provide early insights into the clinical efficacy of DA-1726. Plans are also underway for a Part 3 trial to evaluate early proof of concept.

The MAD Part 2 of the Phase 1 trial is designed as a randomized, placebo-controlled, double-blind study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of multiple ascending doses of DA-1726 in obese but otherwise healthy subjects. Approximately 36 participants will be enrolled, randomized in a 6:3 ratio into four planned cohorts, each receiving four weekly doses of either DA-1726 or a placebo. The first patient for the MAD study received a dose ahead of schedule in late June.

The primary goal of the Phase 1 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 any AEs that lead to treatment discontinuation. Secondary objectives include studying the PK of DA-1726 through serum concentration measurements over time and metabolite profiling at the highest doses. Exploratory endpoints will investigate the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI), among other factors.

DA-1726 is a novel OXM analogue that functions as a dual agonist for GLP1R and GCGR, aimed at treating obesity by decreasing appetite and increasing energy expenditure. Preclinical studies in mice have shown that DA-1726 outperforms other treatments, such as semaglutide and cotadutide, in weight reduction while preserving lean body mass and improving lipid profiles.

NeuroBo Pharmaceuticals is also developing DA-1241, another innovative drug aimed at treating Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1241 is a G-protein-coupled receptor 119 (GPR119) agonist that has shown promising effects on liver inflammation, lipid metabolism, weight loss, and glucose control in preclinical studies.
 

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