Saturday, September 16, 2023
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on addressing cardiometabolic diseases, has announced the commencement of its Phase 2a clinical trial for DA-1241. This novel G-Protein-Coupled Receptor 119 (GPR119) agonist is being evaluated as a potential treatment for nonalcoholic steatohepatitis (NASH). The trial is underway at The Pinnacle Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of Principal Investigator, Dr. David Ramirez.
Hyung Heon Kim, President and Chief Executive Officer of NeuroBo, expressed their dedication to advancing the clinical development of DA-1241 for NASH. They cited promising preclinical and clinical data indicating that DA-1241 could reduce hepatic steatosis, inflammation, liver fibrosis, and improve glucose control. Notably, DA-1241 has exhibited good tolerability in both healthy volunteers and patients with type 2 diabetes mellitus (T2DM).
The Phase 2a trial is divided into two parts, each spanning 16 weeks. Part 1 aims to enroll 49 subjects, with a maximum of 55, who will be randomly assigned to one of three groups: DA-1241 50 mg, DA-1241 100 mg, or a placebo. Part 2, which will commence following a confirmatory preclinical safety study, plans to include 37 subjects, with a maximum of 43, and will investigate the efficacy of DA-1241 in combination with sitagliptin compared to a placebo. The primary endpoint for both parts is the change in alanine transaminase (ALT) levels at Week 16, with various secondary efficacy endpoints and safety assessments.
DA-1241, a GPR119 agonist, has demonstrated therapeutic potential in preclinical studies by promoting the release of gut peptides that benefit liver health, lipid metabolism, weight management, and glucose control. Phase 1a and 1b trials have further supported its safety and efficacy in both healthy volunteers and individuals with T2DM.