NeuroBo Pharmaceuticals cleared to continue Phase 2a trial of DA-1241

NeuroBo Pharmaceuticals announced receipt of Safety Review Committee approval, recommending that the two-part Phase 2a trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist for the treatment of metabolic dysfunction-associated steatohepatitis, continue without modification following a blinded safety review of the first six months of study conduct. The Phase 2a clinical trial is designed to evaluate the efficacy and safety of DA-1241, for the treatment of MASH. The company anticipates a full data readout from the trial in the second half of 2024. “The SRC’s recommendation that the trial continue without modification based on no findings of significant adverse safety trends during the first six months of study conduct, is an early indication of the safety of our most advanced cardiometabolic asset, DA-1241, for patients with presumed MASH, a disease with no currently approved treatment options,” stated Hyung Heon Kim, President and CEO of NeuroBo. “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. 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.”