On Jan. 19, Dong-A ST NeuroBo Pharmaceuticals announced the commencement of the global Phase 2 Part 2 clinical trial for its Metabolic dysfunction-associated steatohepatitis (MASH) treatment DA-1241.
Last May, the company received approval from the U.S. Food and Drug Administration (FDA) for the global Phase 2 Part 1 clinical trial of DA-1241 and began dosing the first patient in September. Phase 1 is designed to assess the efficacy and safety of DA-1241 as a monotherapy.
The current Phase 2 Part 2 trial aims to evaluate the efficacy and safety of combining DA-1241 with Sitagliptin. This trial will involve 37 MASH patients and will be conducted over 16 weeks as a multi-center, randomized, double-blind, placebo-controlled, parallel comparison study.
NeuroBo Pharmaceuticals has been conducting preclinical studies on the combination of DA-1241 with various drugs to develop a versatile treatment for MASH. Preclinical trials combining DA-1241 and Sitagliptin confirmed its safety with no toxicity and an increased anti-inflammatory effect compared to DA-1241 alone.
DA-1241 is a first-in-class GPR119 agonist with promising potential in treating MASH, as observed in preclinical studies. The drug has shown improvements in liver cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose regulation.
NeuroBo Pharmaceuticals plans to conclude both Part 1 and Part 2 of the global Phase 2 trial for DA-1241 in the second half of 2024. Based in Boston, U.S., and listed on NASDAQ, NeuroBo Pharmaceuticals is a global R&D outpost of Dong-A Socio Group, responsible for the global development and commercialization of DA-1241 and DA-1726. DA-1726, a GLP1R/GCGR dual agonist in development for obesity and MASH treatment, had its global Phase 1 IND application submitted in December last year.