NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, said Wednesday that the global phase 1 clinical trial of DA-1726 for obesity treatment has demonstrated excellent safety, tolerability, and dose-linear pharmacokinetic characteristics

The global phase 1 study of DA-1726 is a randomized, double-blind, placebo-controlled study comprised of a phase 1 single-dose escalation study and a phase 2 multiple-dose escalation study to confirm the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.

Part 1 consisted of a single dose of DA-1726 or placebo in 45 obese patients and healthy adults. Its results demonstrated excellent safety and tolerability, with no serious adverse events and only five mild adverse events.

Given the dose-linear pharmacokinetic profile across the dose range explored in Part 1, NeuroBo Pharmaceuticals plans to conduct additional trials to explore the maximum tolerated dose.

Part 2 will include 36 healthy obese patients and 36 healthy adults who will receive repeated four-week doses of DA-1726 or placebo, with results expected in the first quarter of 2025. The first patient dosing in part 2 occurred in June at designated clinical sites in the United States.

After completing Parts 1 and 2 of the global Phase 1 study of DA-1726, NeuroBo Pharmaceuticals plans to initiate a global Phase 1 Part 3 in the second quarter of 2025. Part 3 will be a 24-week parallel comparative study with repeat dosing of DA-1726 or placebo. The 12-week interim results are expected in the first half of 2026, looking at weight change, muscle-to-body fat loss, changes in food intake, and maximum tolerated dose.

DA-1726 is a drug candidate in development as an oxyntomodulin analog for treating obesity. It acts simultaneously at GLP-1 and glucagon receptors to suppress appetite, stimulate insulin secretion, and increase peripheral basal metabolism, ultimately leading to weight loss and glycemic control.

In a comparative preclinical study, the GLP-1 glucagon dual agonist DA-1726 demonstrated superior weight loss compared to the GLP-1 receptor agonist liraglutide despite similar food intake. It also achieved comparable weight loss and superior cholesterol-lowering effects, even with higher food intake, compared to the GLP-1 and GIP dual agonist tripeptide.

It also demonstrated superior weight loss, decreased fat mass, increased relative lean body mass, and decreased blood glucose compared to the same GLP-1 and glucagon dual agonist, survodutide.

“The excellent safety, tolerability, and dose-linear pharmacokinetic data from the global phase 1 study of DA-1726 will enable us to rapidly advance the phase 2 study,” NeuroBo Pharmaceuticals CEO Kim Hyung-heon said. “We believe that DA-1726 has the potential to be a revolutionary treatment for obesity that outperforms existing treatments. We plan to present phase 2 data in the first quarter of 2025 and initiate a phase 3 study in the second quarter.”

NeuroBo Pharmaceuticals is a Nasdaq-listed company based in Boston, Mass., and is the Dong-A Socio Group's global R&D advanced base responsible for the global development and commercialization of DA-1241 and DA-1726. DA-1241, developed to treat metabolic dysfunction-associated steatohepatitis (MASH), is in a global phase 2 study and is expected to report clinical results in late 2024.