On May 3, the U.S. Food and Drug Administration (FDA) approved the phase 2 clinical trial of "DA-1241", a new drug being developed by NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, as a treatment for Non-Alcoholic Steatohepatitis (NASH).
This disease occurs when there is an accumulation of triglycerides in liver cells, regardless of alcohol consumption. It is characterized by liver inflammation and fibrosis, which can lead to serious liver conditions such as cirrhosis, liver cancer, and liver failure. The prevalence of NASH is 2-4% worldwide and 3-5% in the United States, and currently, there is no known cure for the disease.
DA-1241 is a first-in-class new drug with GPR119 agonist mechanism that has demonstrated potential as a NASH treatment in preclinical trials. It has been shown to have beneficial effects on liver cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose control following administration.
The phase 2 clinical trial will aim to confirm the safety and effectiveness of DA-1241 in 86 patients with NASH, using a multicenter, randomized, double-blind, placebo-controlled, parallel comparison method for 16 weeks.
NeuroBo Pharmaceuticals is planning to start the phase 2 clinical trial for DA-1241 in the United States in the third quarter of this year and complete it in the second half of 2024. The company is listed on Nasdaq and is based in Boston, USA. It is also the global research and development (R&D) base of Dong-A Socio Holdings, which is responsible for the global development and commercialization of DA-1241 and another drug called DA-1726, which is being developed as an obesity and NASH treatment.
In preclinical studies, DA-1726 has shown not only appetite suppression but also weight control effects due to an increase in basal metabolic rate. The company plans to submit a global phase 1 clinical trial IND for DA-1726 in the second half of this year.
"The company will focus on developing DA-1241 as the first treatment for NASH and successfully complete the global phase 2 clinical trial," said Dong-A ST's official. "With the approval of the phase 2 clinical trial of DA-1241, the company plans to accelerate preparations for the global phase 1 clinical trial of DA-1726 and proceed with the clinical trial as scheduled."
