NeuroBo Pharmaceuticals Concludes Phase 2a Trial of DA-1241 for MASH Treatment

NeuroBo Pharmaceuticals, Inc., a biotechnology firm based in Cambridge, Massachusetts, has successfully concluded the final patient visit in its two-part, Phase 2a clinical trial for DA-1241. This novel G-Protein-Coupled Receptor 119 (GPR119) agonist is being examined for its efficacy and safety in treating metabolic dysfunction-associated steatohepatitis (MASH). The company anticipates the release of topline data from both parts of this trial by December 2024.

Hyung Heon Kim, the President and CEO of NeuroBo, highlighted this achievement as a crucial milestone for DA-1241, bringing the company closer to determining the drug’s potential in treating MASH. The Phase 2a trial is divided into two parts: Part 1 compares DA-1241 to a placebo, while Part 2 evaluates the effectiveness of DA-1241 combined with sitagliptin, a DPP-4 inhibitor. The company expects that the combination will have synergistic effects.

Previous studies have shown that DA-1241 was well-tolerated in healthy individuals and those with type 2 diabetes mellitus (T2DM). NeuroBo remains optimistic about DA-1241's unique action mechanism targeting inflammation associated with MASH, potentially offering a safe and effective treatment option.

The Phase 2a clinical trial is designed as a 16-week, multicenter, randomized, double-blind, placebo-controlled study. It enrolled 109 patients, with 95 completing the dosing regimen. In Part 1, patients were randomized into three groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2 involved two groups: DA-1241 100 mg combined with sitagliptin 100 mg, or placebo.

The primary endpoint for both parts of the trial is the change in alanine transaminase (ALT) levels from baseline after 16 weeks. Secondary endpoints include normalization of ALT levels, changes in total cholesterol, low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids from baseline. Safety is assessed by monitoring adverse events (AEs) and serious adverse events (SAEs), as well as any laboratory abnormalities.

DA-1241 is a groundbreaking G-Protein-Coupled Receptor 119 (GPR119) agonist, showing potential both as a standalone and combination therapy for MASH and T2DM. It stimulates gut peptides such as GLP-1, GIP, and PYY, which play crucial roles in glucose and lipid metabolism, as well as weight management. Preclinical studies have supported DA-1241's efficacy, showing positive effects on liver inflammation, lipid levels, and glucose control. Phase 1 trials have also demonstrated that DA-1241 is well-tolerated.

NeuroBo Pharmaceuticals is a clinical-stage biotech company focusing on cardiometabolic diseases. Besides DA-1241, the company is also developing DA-1726 for obesity treatment. DA-1726 is an oxyntomodulin (OXM) analogue that acts as a dual agonist for glucagon-like peptide-1 receptor and glucagon receptor, potentially leading to better weight loss outcomes compared to selective GLP1R agonists.

NeuroBo remains committed to advancing these treatments with the goal of providing new therapeutic options for patients with MASH, T2DM, and obesity.