NeuroBo Secures Safety Review Committee Approval for MASH Treatment Trial
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) has received Safety Review Committee (SRC) approvalrecommending that the company’s two-part Phase 2a trial of DA-1241, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), continue without modification following a blinded safety review of the first six months of study conduct.
Commenting on the news, Hyung Heon Kim, President and Chief Executive Officer of NeuroBo, said, “Based on the pre-clinical and clinical evidence generated to date, DA-1241 has demonstrated reduced hepatic steatosis, hepatic inflammation and liver fibrosis, while also improving glucose control, and was shown to be well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM). We continue to believe that the mechanism of action of DA-1241 will translate into a safe and effective treatment for MASH and look forward to another blinded SRC analysis once the first 50% of patients have been randomized and dosed.”
The company’s two-part Phase 2a trial of DA-1241 is designed to be two 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical studies to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH.
NeuroBo expects to deliver full data readout from the trial in the second half of 2024.
DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone or combination therapy for both MASH and Type 2 diabetes.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit www.neurobopharma.com.
