Dong-A ST US Subsidiary Applies for Phase 1 Clinical Trial of 'GLP-1' Obesity Drug

NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, announced on the 2nd that it has submitted an Investigational New Drug (IND) application for the Phase 1 clinical trial of 'DA-1726', a drug under development for obesity treatment, to the U.S. Food and Drug Administration (FDA).

Dong-A ST (top) and Neurobo Pharmaceuticals logos [Photo by each company]

This clinical trial will be conducted in two parts with 81 obese patients to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726. It will be randomized, double-blind, placebo-controlled, and parallel-group. In the first part, 45 patients will receive a single dose of either DA-1726 or placebo. In the second part, 36 patients will undergo repeated dosing of DA-1726 or placebo for 4 weeks. NeuroBo plans to start this Phase 1 trial in the first half of this year and complete it by the first half of next year.

NeuroBo, a Nasdaq-listed company based in Boston, USA, is responsible for the global development and commercialization of DA-1726 as well as DA-1241, a treatment for non-alcoholic steatohepatitis (NASH). In September 2022, Dong-A ST became the largest shareholder of NeuroBo and incorporated it as a subsidiary through a licensing agreement for the two drug candidates. DA-1241 is currently undergoing a global Phase 2 clinical trial.

DA-1726 is a novel drug candidate in development as an oxyntomodulin analogue for obesity treatment. It acts simultaneously on glucagon-like peptide-1 (GLP-1) receptors and glucagon receptors to suppress appetite, promote insulin secretion, and increase basal metabolic rate in peripheral tissues, ultimately inducing weight loss and blood glucose control.

In preclinical studies, DA-1726 demonstrated superior weight loss effects compared to semaglutide, an existing GLP-1 analogue, at similar food intake levels in obese animal models. Compared to tirzepatide, which acts on both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), DA-1726 showed similar weight loss effects despite higher food consumption.

Hyungheon Kim, CEO of NeuroBo, stated, “The global Phase 1 clinical trial of DA-1726 marks the first step toward developing an obesity treatment that not only suppresses fat absorption and appetite but also increases energy metabolism to burn fat. We will successfully initiate the Phase 1 trial of DA-1726 and develop an advanced obesity treatment that can innovatively address obesity issues.”

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