NeuroBo Pharmaceuticals completes final dosing in US phase 2 trial for MASH treatment

Dong-A ST said Tuesday that its Boston-based, Nasdaq-listed subsidiary, NeuroBo Pharmaceuticals, has completed the final patient dosing in part 1 and part 2 of the U.S.-based phase 2 clinical trial for DA-1241, a treatment under development for metabolic dysfunction-associated steatohepatitis (MASH).

The phase 2 clinical trial for DA-1241 was conducted in two parts. Both part 1 and part 2 were 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, with a total of 95 MASH patients completing dosing.

In part 1, the efficacy and safety of DA-1241 were evaluated by administering DA-1241 at two dosages: 50 mg and 100 mg. Part 2 examined the efficacy and safety of a combination of DA-1241 and sitagliptin, a treatment for type 2 diabetes. 

Topline data from parts 1 and 2 of the DA-1241 phase 2 clinical trial is expected to be available by the end of this year.

DA-1241 is a first-in-class synthetic drug that activates the G protein-coupled receptor 119 (GPR119). Animal studies have shown its potential to improve blood glucose and lipid levels and act directly on the liver to reduce inflammation and fibrosis, supporting its development as a treatment for MASH.

 Kim Hyung-heon, CEO of NeuroBo Pharmaceuticals, said that with the final dosing in the DA-1241 phase 2 trial complete, the company is now one step closer to securing topline data.