NeuroBo's DA-1241 Phase 2a Trial Gets Green Light from Safety Panel

NeuroBo Pharmaceuticals, a firm dedicated to the advancement of treatments for cardiometabolic disorders, has received positive news regarding its ongoing Phase 2a clinical trial. The trial, which is assessing the safety and efficacy of DA-1241—a G-Protein-Coupled Receptor 119 (GPR119) agonist—has been given the green light to proceed without any changes by the Safety Review Committee (SRC). This decision was made after a six-month blinded safety review showed no significant adverse safety trends.

The Phase 2a trial is divided into two parts, both of which are structured as 16-week, multicenter, randomized, double-blind, and placebo-controlled studies. The first part is comparing the effects of DA-1241 against a placebo, with an expected enrollment of 49 subjects, potentially increasing to 55 to account for early discontinuations. The subjects are divided into three treatment groups in a 1:2:1 ratio, receiving either 50 mg or 100 mg of DA-1241 or a placebo. The second part of the trial is looking into the combined efficacy of DA-1241 with sitagliptin compared to a placebo, with an anticipated enrollment of approximately 37 subjects. These subjects will be randomized into two treatment groups in a 2:1 ratio.

The primary goal of the trial is to measure the change in alanine transaminase (ALT) levels from baseline at the 16-week mark. Secondary objectives include assessing the normalization rate of ALT, as well as changes in total cholesterol, low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids. The safety of the treatment will be monitored through the tracking of adverse events, serious adverse events, discontinuations due to adverse events, and laboratory abnormalities.

DA-1241 has shown promise in preclinical studies, where it has been found to promote the release of beneficial gut peptides that positively impact liver inflammation, lipid metabolism, weight loss, and glucose metabolism. In previous Phase 1 trials, DA-1241 was well tolerated by both healthy individuals and those with type 2 diabetes mellitus (T2DM).

NeuroBo Pharmaceuticals is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and T2DM, as well as DA-1726 for obesity treatment. DA-1241 works by activating GPR119, which is linked to the release of key gut peptides that help in managing liver conditions and glucose levels. The company's commitment to transforming treatments for cardiometabolic diseases is evident through their innovative approach to drug development.

The full data from the Phase 2a trial is expected to be released in the latter half of 2024, providing further insights into the potential of DA-1241 as a treatment for MASH, a condition that currently lacks approved treatment options.