NeuroBo Pharmaceuticals Receives First Site IRB Approval for its Phase 2a Clinical Trial of DA-1241

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NeuroBo Pharmaceuticals Receives First Site IRB Approval for its Phase 2a Clinical Trial of DA-1241

NeuroBo Pharmaceuticals (NASDAQ: NRBO ), Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that it has received the first site Institutional Review Board (IRB) approval for Zeid Kayali, M.D., Medical Director at Inland Empire Liver Foundation, in Rialto, CA, to proceed with the Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment of nonalcoholic steatohepatitis (NASH). The dosing of the first patient in part one of the two-part, Phase 2a clinical trial of DA-1241 is expected to occur in September of 2023.

"With this first IRB approval, we have achieved another significant milestone in the clinical development of DA-1241," stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo. "This promising cardiometabolic asset has been shown to be well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM) in Phase 1a/1b clinical studies. Additionally, the therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of NASH and T2DM where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. As a result, we believe that the mechanism of action of DA-1241 will translate into a safe and effective treatment for NASH. We look forward to working closely with our contract research organization (CRO) partner and our investigators, such as Dr. Kayali, to start screening this month and expect to dose the first patient in September of this year. The two-part design provides optionality for an interim analysis in the first half of 2024 and an anticipated full data readout in the second half of 2024."

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.

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