NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, said Thursday that it has initiated the dosing of the first patient in Part 2 of its global phase 1 clinical trial of DA-1726, a drug being developed for treating obesity, in the United States.
NeuroBo Pharmaceuticals received the global phase 1 approval for DA-1726 from the U.S. Food and Drug Administration in January. It is a randomized, double-blind, and placebo-controlled trial divided into Part 1 single-dose escalation study, and Part 2 multiple-dose escalation study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726.
The first patient dose in Part 2 was administered on Wednesday (local time) at a designated clinical site in the U.S. Part 2 will include 36 healthy obese patients, who will repeatedly receive four-week doses of DA-1726 or placebo, with results expected in the first quarter of next year.
Part 1, which began dosing the first cohort of patients in April, is a single-dose trial of DA-1726 or placebo in 45 healthy adult obese patients. Top-line results are expected in the third quarter of this year.
Following the completion of Part 1 single-dose escalation study and Part 2 multiple-dose escalation study of DA-1726, NeuroBo Pharmaceuticals plans to initiate a global phase 1 Part 3 in the second half of 2025. Part 3 will be a 24-week parallel comparative study with repeated doses of DA-1726 or placebo. Interim results from the 12-week study are expected in the first half of 2026, after confirming weight change, muscle-to-body fat loss, changes in food intake, and maximum tolerated dose.
According to Dong-A ST, DA-1726 is a drug candidate in development as an oxyntomodulin analog for treating obesity. It acts simultaneously on GLP-1 and glucagon receptors to suppress appetite, stimulate insulin secretion, and increase basal metabolism in the periphery, ultimately leading to weight loss and glycemic control.
The GLP-1, glucagon dual agonist DA-1726 demonstrated superior weight loss compared to the GLP-1 receptor agonist semaglutide despite similar food intake in a comparative preclinical study. It demonstrated similar weight loss and superior cholesterol-lowering effects to the GLP-1 and GIP dual agonist tirzepatide despite higher food intake.
It also demonstrated superior weight loss, decreased fat mass, increased relative lean body mass, and decreased blood sugar compared to the same GLP-1 and glucagon dual agonist, servodutide.
"The initiation of Part 2 while simultaneously conducting Part 1 of the global phase 1 study is expected to accelerate the development of DA-1726, which has shown the potential to develop a differentiated obesity treatment," NeuroBo Pharmaceuticals CEO Kim Hyung-heon said. "We will make every effort to complete Part 1 and Part 2 and proceed smoothly with Part 3."