NeuroBo Completes Key Phase 2a Study For DA-1241 In MASH Treatment

NeuroBo Pharmaceuticals, a biotech company focused on treating cardiometabolic conditions, has announced the completion of patient visits in its Phase 2a clinical trial for DA-1241, an investigational G-Protein-Coupled Receptor 119 (GPR119) agonist targeting metabolic dysfunction-associated steatohepatitis (MASH). 

Hyung Heon Kim, President and Chief Executive Officer of NeuroBo, said in a statement, "Completion of patient dosing in the Phase 2a clinical trial of DA-1241, in patients with presumed MASH, marks an important milestone for this promising cardiometabolic asset, bringing us one step closer to the topline data readout from both Part 1 and Part 2 of the Phase 2a clinical trial expected in December of this year.”

He further added, "As a reminder, Part 1 of this Phase 2a trial is exploring DA-1241 compared to placebo, while Part 2 is investigating the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, which we believe will show synergistic effects compared to DA-1241, alone. In a previously reported Phase 1 study, DA-1241 was well tolerated in both healthy volunteers and individuals diagnosed with type 2 diabetes mellitus (T2DM). Based on the pre-clinical and clinical evidence, we maintain our belief that the distinctive mechanism of action DA-1241, which addresses the inflammation linked to MASH, will result in a safe and effective therapeutic option for this disease."

This Phase 2a trial consists of two separate, 16-week studies conducted across multiple centers. Both studies are double-blind, randomized, and placebo-controlled; parallel studies were carried out to assess DA-1241's effectiveness and safety in MASH patients.

In total, 109 participants were initially enrolled, with 95 completing the treatment. The trial has two parts: Part 1 examines DA-1241 alone at doses of 50 mg and 100 mg against a placebo, with participants divided into three groups at the ratio of 1:2:1. On the other hand, Part 2 evaluates the combined effect of DA-1241 at 100 mg and sitagliptin at 100 mg versus placebo at the ratio of 2:1, with participants divided into two groups. 

The main outcome measure for both parts is the change in alanine transaminase (ALT) levels after 16 weeks. Secondary measures include the proportion of patients who achieve normalized ALT levels, as well as changes in cholesterol, low and high-density lipoprotein cholesterol,  triglycerides, and free fatty acids. Safety data will be gathered by tracking adverse events and serious adverse events, including any leading to discontinuation or lab abnormalities.