NeuroBo OKd to Continue With Its Phase 2a for MASH

 Blinded Safety Review Completed for the First 6 Months of the Phase 2a Clinical Trial Conduct; Recommending Trial Continue Without Modification

Full Data Readout Expected in the Second Half of 2024

NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced receipt of Safety Review Committee (SRC) approval, recommending that the two-part Phase 2a trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), continue without modification following a blinded safety review of the first six months of study conduct. The Phase 2a clinical trial is designed to evaluate the efficacy and safety of DA-1241, for the treatment of MASH. The company anticipates a 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. Part 1 is exploring the efficacy of DA-1241 versus placebo, and is expected to enroll 49 subjects, with a planned maximum of 55 subjects to account for early discontinuations. Subjects will be randomized in a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2, which will explore the efficacy of DA-1241 in combination with sitagliptin versus placebo, is expected to enroll approximately 37 subjects who will be randomized in a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.

For both Part 1 and Part 2, the primary endpoint is the change from baseline in alanine transaminase (ALT) levels at Week 16. 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. Safety will be evaluated by monitoring adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation and laboratory abnormalities.

https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-receives-safety-review-committee-approval-to-continue-with-its-phase-2a-clinical-trial-evaluating-da-1241-for-the-treatment-of-mash-302087594.html