Dong-A ST US Subsidiary Receives Approval for Phase 2 Clinical Trial of NASH Treatment

Dong-A ST announced on the 3rd that its subsidiary NeuroBo Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial plan of ‘DA-1241,’ which is being developed as a treatment for non-alcoholic steatohepatitis (NASH).

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

DA-1241 is being developed as a first-in-class drug with a GPR119 agonist mechanism. Its potential as a NASH treatment was confirmed in preclinical studies. Improvements were observed in liver cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose regulation after administration of DA-1241. This clinical trial will evaluate the efficacy and safety of DA-1241 in 86 NASH patients over 16 weeks using a multicenter, randomized, double-blind, placebo-controlled, parallel-group design.

NeuroBo plans to initiate the U.S. Phase 2 clinical trial of DA-1241 by the third quarter of this year and complete it by the second half of next year.

NASH is a disease characterized by the accumulation of neutral fat in liver cells regardless of alcohol consumption. It features inflammation and fibrosis within the liver and can lead to serious liver diseases such as cirrhosis, liver cancer, and liver failure. The prevalence is 2-4% worldwide and 3-5% in the U.S., but no approved treatments have been developed yet.

NeuroBo’s other candidate, DA-1726, which is being developed as a treatment for obesity and NASH, is expected to submit a global Phase 1 IND in the second half of this year. DA-1726 acts simultaneously on GLP-1 and glucagon receptors to suppress appetite, promote insulin secretion, and increase basal metabolic rate in peripheral tissues, ultimately inducing weight loss. The company explained, "Unlike semaglutide-class obesity treatments that showed only appetite suppression in preclinical studies, DA-1726 demonstrated weight control effects due to both appetite suppression and increased basal metabolic rate."

A Dong-A ST official stated, “We will focus our capabilities to make DA-1241 the first NASH treatment and successfully complete the global Phase 2 clinical trial,” adding, “We will also accelerate preparations for the global Phase 1 clinical trial of DA-1726 and do our best to conduct the clinical trials according to the planned schedule.”