HighTide Therapeutics Inc., (HKG: 2511), a biopharmaceutical company based in China, has announced the completion of patient enrollment for two Phase III clinical studies of its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) for the treatment of type 2 diabetes (T2DM).
The studies include the multi-center, randomized, double-blind, placebo-controlled SYMPHONY-1, which assesses the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control following dietary and exercise interventions, and the SYMPHONY-2 study, which evaluates HTD1801’s efficacy and safety in T2DM patients with inadequate metformin control. Both trials aim to evaluate HTD1801’s impact on glycated hemoglobin, glucose metabolism, blood lipids, liver injury/inflammation markers, and inflammation in T2DM patients.
HTD1801 is an oral anti-inflammatory and metabolic modulator designed for the treatment of metabolic and digestive system diseases. Composed of the ionic salt derived from ursodeoxycholic acid and berberine, HTD1801 represents a new molecular entity with a distinct mechanism of action. It targets the improvement of glucose metabolism, insulin resistance, lipid metabolism, and liver inflammation, offering a comprehensive treatment approach for complex metabolic diseases such as T2DM.- Flcube.com
