NeuroBo Pharmaceuticals Doses First Patient in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH

Two-Part Design Provides Optionality for Interim Analysis in First Half of 2024

Full Data Readout Expected in the Second Half of 2024

Excerpt from the Press Release:

BOSTON, Sept. 15, 2023 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced dosing of the first patient in its two-part, Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment of nonalcoholic steatohepatitis (NASH), at The Pinnacle Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of Principal Investigator, Dr. David Ramirez.

“Dosing the first patient, on time, is a testament to our commitment to the clinical development of DA-1241 in patients with NASH,” stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. “Based on the pre-clinical and clinical evidence generated to date, DA-1241 has demonstrated reduced hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control, and was shown to be well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM). Given this data, we believe that the mechanism of action of this promising cardiometabolic asset will translate into a safe and effective treatment for NASH, a disease with no current treatment options. The two-part design of this trial provides optionality for a potential interim analysis in the first half of 2024 and we expect to report the full data in the second half of 2024.”

Each of the two-parts of the 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 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.

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