NeuroBo Completes Patient Enrollment in Phase 2a MASH Trial for DA-1241

NeuroBo Pharmaceuticals, a clinical-stage biotechnology firm, has successfully completed the enrollment phase for Part 1 of its Phase 2a clinical trial. The trial is assessing the efficacy and safety of DA-1241, a new GPR119 agonist, in treating metabolic dysfunction-associated steatohepatitis (MASH). The study involved approximately 49 patients who were divided into three groups to receive either 50 mg or 100 mg of DA-1241 or a placebo.

Hyung Heon Kim, NeuroBo's President and CEO, highlighted the significance of this development, indicating that it marks a crucial step in advancing their cardiometabolic drug candidates. He also mentioned that Part 2 of the trial is underway, which will examine the combined effects of DA-1241 with sitagliptin, a DPP-4 inhibitor, and is expected to demonstrate enhanced benefits over DA-1241 alone. The drug has previously shown good tolerance in both healthy individuals and those with type 2 diabetes mellitus (T2DM). The company is optimistic that DA-1241's unique mechanism, which targets inflammation associated with MASH, will offer a safe and effective treatment option.

Designed as 16-week studies, both parts of the Phase 2a trial are multicenter, randomized, double-blind, and placebo-controlled. They aim to evaluate DA-1241's impact on subjects with presumed MASH. Part 2 will include around 37 participants and will compare the effects of the combination therapy against a placebo.

The primary goal of the trials is to measure changes in alanine transaminase (ALT) levels at Week 16 from baseline. Secondary objectives include assessing the normalization of ALT levels, changes in total cholesterol, and levels of low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids. Safety will be monitored through adverse events and serious adverse events, as well as laboratory abnormalities.

DA-1241 is a promising drug candidate with potential as both a standalone and combination therapy for MASH and T2D. It works by activating GPR119 in the gut, leading to the release of important peptides that aid in glucose and lipid metabolism and promote weight loss. Preclinical studies have shown its potential to reduce liver inflammation and improve glucose control.

NeuroBo Pharmaceuticals is dedicated to transforming the treatment of cardiometabolic diseases with its pipeline, which includes DA-1241 for MASH and T2DM, and DA-1726 for obesity. The latter is an oxyntomodulin analogue that acts as a dual agonist for GLP1R and GCGR, potentially leading to superior weight loss compared to selective GLP1R agonists.