NeuroBo Pharma Gets Approval To Proceed With Phase 2a Trial For DA-1241 To Treat MASH; Stock Up 8%

(RTTNews) - Biotechnology company NeuroBo Pharmaceuticals, Inc. (NRBO) announced Wednesday the receipt of Safety Review Committee (SRC) approval, recommending that the two-part Phase 2a trial of DA-1241 can continue without modification following a blinded safety review of the first six months of study conduct.

DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)

The Phase 2a clinical trial is designed to evaluate the efficacy and safety of DA-1241, for the treatment of MASH. The company anticipates full data readout from the trial in the second half of 2024.

Each of the two-parts of the Phase 2a trial of DA-1241 are designed to be 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical studies to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH.

For both Part 1 and Part 2, the primary endpoint is the change from baseline in alanine transaminase (ALT) levels at Week 16. The secondary efficacy endpoints include the proportion of subjects with normalization of ALT, absolute change in total cholesterol, low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids from baseline, among others.