Dong-A ST US Subsidiary Begins Dosing in Phase 1 Part 2 Clinical Trial of Obesity Treatment

Dong-A ST announced on the 27th that its U.S. subsidiary, Neurobo Pharmaceuticals, has initiated the first patient dosing in the United States for Part 2 of the global Phase 1 clinical trial of DA-1726, a drug under development for obesity treatment.

Neurobo Pharmaceuticals Logo
Photo by Neurobo

Neurobo received approval from the U.S. Food and Drug Administration (FDA) for the global Phase 1 clinical trial of DA-1726 in January. This trial is divided into Part 1, a single ascending dose study, and Part 2, a multiple ascending dose study, conducted in a randomized, double-blind, placebo-controlled manner to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726.

The first patient dosing for Part 2 took place on the 26th at a clinical trial site in the United States. The Phase 1 Part 2 trial involves 36 healthy obese subjects who will receive repeated doses of DA-1726 or placebo over four weeks. The clinical results are expected to be disclosed in the first quarter of 2025. Part 1 of the trial, which is ongoing with 45 healthy adult obese subjects, is expected to have its results announced in the third quarter of this year.

Neurobo plans to proceed to Part 3 of the Phase 1 trial in the second quarter of next year after completing Parts 1 and 2. This will be a parallel comparison study involving repeated administration of DA-1726 or placebo over 24 weeks to assess changes in body weight, reduction rate of body fat relative to muscle mass, changes in food intake, and maximum tolerated dose.

DA-1726 is a new drug candidate under development as an obesity treatment in the oxytomodulin analog class. In addition to targeting the glucagon-like peptide-1 (GLP-1) receptor, which has recently sparked a surge in obesity treatments, it simultaneously acts on the glucagon receptor to suppress appetite, promote insulin secretion, and increase basal metabolic rate, ultimately inducing weight loss and blood sugar control. In comparative preclinical studies, DA-1726 demonstrated superior weight loss effects compared to Novo Nordisk’s Wegovy, a GLP-1 receptor obesity treatment, despite similar food intake. It also showed comparable weight loss and superior cholesterol-lowering effects compared to Eli Lilly’s Zepbound, which acts on both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), even with higher food intake.

Kim Hyung-heon, CEO of Neurobo, stated, “Having conducted Part 1 of the global Phase 1 trial and simultaneously starting Part 2, we expect the development of DA-1726, a differentiated obesity treatment, to accelerate. We will make every effort to successfully complete Parts 1 and 2 and to smoothly proceed with Part 3.”