NeuroBo Pharmaceuticals Inc., a biotechnology company, announced on Wednesday that it received approval from the Safety Review Committee (SRC) to proceed with its two-part Phase 2a trial of DA-1241. The trial was approved to continue without any changes, following a six-month review of study conduct.
DA-1241, a novel treatment, uses an agent known as a G-Protein-Coupled Receptor 119 (GPR119) agonist to treat metabolic dysfunction-associated steatohepatitis (MASH), a liver disease.
The primary aim of the Phase 2a clinical trial is to assess the efficacy and safety of DA-1241 in treating MASH. NeuroBo Pharmaceuticals expects to have a full readout of data from this trial by the second half of 2024.
Each segment of the trial is structured as a 16-week study, carried out simultaneously at multiple centers. The studies are randomized, double-blind, and placebo-controlled, with the intention of evaluating the efficacy and safety of DA-1241 in subjects presumed to have MASH.
The primary measure of success or "endpoint" for both parts of the trial is the change in levels of alanine transaminase (ALT), a liver enzyme, from the starting point to week 16. Secondary measures include the number of subjects whose ALT levels return to normal, as well as changes in total cholesterol, both types of lipoprotein cholesterol, triglycerides, and free fatty acids, among others.
