NeuroBo Pharmaceuticals Receives First Site IRB Approval for its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH
"With this first IRB approval, we have achieved another significant milestone in the clinical development of DA-1241," stated
The two-part, Phase 2a trial of DA-1241 is designed to be a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the efficacy and safety of DA-1241 in subjects with presumed NASH and confirmed pre-diabetes or T2DM.
- Part 1: will explore 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: will explore the efficacy of DA-1241 in combination with sitagliptin versus placebo and will begin after completion of a confirmatory preclinical safety study of DA-1241 in combination with sitagliptin. It is expected to enroll 37 subjects, with a planned maximum of 43 subjects to account for early discontinuations, and subjects will be randomized in a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.
For both Parts 1 and 2, the primary endpoint is the change from baseline in alanine transaminase (ALT) levels at Week 16. Key, secondary efficacy endpoints include the proportion of subjects with normalization of ALT, absolute change in aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT), and alkaline phosphatase (ALP) from baseline, and absolute change in total cholesterol, low- and high-density lipoprotein cholesterol, triglyceride, 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.
DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both NASH and T2DM. In preclinical studies, DA-1241 demonstrated that GPR-119 agonism promotes the release of the key gut peptides GLP-1, GIP, and PYY, which have a beneficial effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism. The therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of NASH and T2DM whereby DA-1241 reduced hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. Furthermore, in Phase 1a and 1b trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM.
Forward Looking Statements
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