NeuroBo Pharmaceuticals has announced positive top-line results from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity. The data revealed a favorable safety profile, tolerability, and dose-linear pharmacokinetics (PK) in obese participants.
Phase 1 Trial Details
The Phase 1 clinical trial's SAD Part 1 involved 45 obese but otherwise healthy participants. These individuals were randomized in a 6:3 ratio to receive either DA-1726 or a placebo, respectively, under double-blind conditions. The study found that single ascending doses of DA-1726 were safe and well-tolerated, with no serious adverse events reported. Only five subjects in the DA-1726 treatment group experienced adverse events (AEs), compared to three subjects in the placebo group. The trial also observed a dose-linear PK profile across the investigated dose range. NeuroBo is adding additional cohorts to the SAD Part 1 to further explore the maximum tolerated dose.
Executive Insights
"The safety, tolerability, and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging and allowed for the accelerated initiation of our multiple ascending dose (MAD) study," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. He added, "Based on the preclinical data generated to date, as well as DA-1726's balanced activation of GLP1R and glucagon receptors, which increases energy expenditure, we continue to believe that DA-1726 may become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials."
Ongoing and Future Studies
The MAD Part 2 of the Phase 1 trial is currently underway. It is designed as a randomized, placebo-controlled, double-blind study to assess the safety, tolerability, PK, and PD of multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Approximately 36 participants are expected to be enrolled and randomized in a 6:3 ratio into four cohorts, each receiving four weekly administrations of DA-1726 or placebo. Top-line data from the MAD Part 2 is anticipated in the first quarter of 2025. Part 3 of the trial is planned to explore early proof of concept.
Trial Endpoints
The primary endpoint 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 AEs leading to treatment discontinuation. Secondary endpoints include assessing the PK of DA-1726 via serum concentrations over time and metabolite profiling at the highest doses. Exploratory endpoints will examine the effect of DA-1726 on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI).
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). It is designed for once-weekly subcutaneous administration. Pre-clinical studies in mice have shown that DA-1726 resulted in improved weight loss compared to semaglutide and cotadutide. DA-1726 also elicited similar weight reduction compared to tirzepatide and survodutide, while preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide.
