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NeuroBo Pharmaceuticals Completes Enrollment of Part 1 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH
Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., April 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a
About this update from Metavia Inc.
[{"type":"text","content":"Full Data Readout Expected in the Second Half of 2024\nCAMBRIDGE, Mass., April 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of enrollment of Part 1 of its two-part, Phase 2a clinical trial evaluating the efficacy and safety, of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Approximately 49 patients with presumed MASH have been randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.\n\n\"Enrollment of the final patient in Part 1 our Phase 2a clinical trial of DA-1241, in patients with presumed MASH, is another important event in the clinical development of our cardiometabolic assets,\" stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. \"Part 2 of this Phase 2a trial, exploring the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, continues to enroll patients, which we believe will show synergistic effects compared to DA-1241 alone. As previously reported, DA-1241 was well tolerated in healthy volunteers and in patients with type 2 diabetes mellitus (T2DM). Based on the pre-clinical and clinical evidence to date, we believe that the unique mechanism of action of this promising cardiometabolic asset, targeting the inflammation associated with MASH, will translate into a safe and effective treatment for this disease. We look forward to reporting the full trial data expected in the second half of this year.\"\nEach 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 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.\nFor 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 nor...