NeuroBo Pharmaceuticals Inc. announced that it has received the first site Institutional Review Board (IRB) approval for Zeid Kayali, M.D., Medical Director at Inland Empire Liver Foundation, in Rialto, CA, to proceed with the Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled receptor 119 (GPR119) agonist, for the treatment of nonalcoholic steatohepatitis (NASH). The dosing of the first patient in part one of the two-part, Phase 2a clinical trial ofDA-1241 is expected to occur in September of 2023. Additionally, the therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of NASH and T2DM where DA-1241 reduced hepatic steatohepatitis, and improved glucose control.

As a result, the mechanism of action of DA-1241 will translate into a safe and effective treatment for NASH. The two-part design provides optionality for an interim analysis in the first half of 2024 and an anticipated full data readout in the second half of 2024.XM 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.