By Fineline Cube 
China-based HighTide Therapeutics Inc. (HKG: 2511) has announced positive results from two Phase III clinical studies (SYMPHONY-1 and SYMPHONY-2) for its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) in treating type 2 diabetes (T2DM). Both studies achieved their primary endpoints, demonstrating significant improvements in glycemic control and supporting the filing of a New Drug Application (NDA) in China within this year.
SYMPHONY Studies: Design and Outcomes
The SYMPHONY-1 study evaluated the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control despite dietary and exercise interventions. The SYMPHONY-2 study focused on T2DM patients with inadequate glycemic control on metformin. Both trials were multi-center, randomized, double-blind, and placebo-controlled. After 24 weeks of treatment, HTD1801 showed a statistically significant reduction in HbA1c levels compared to placebo, with continuous improvement observed throughout the treatment period. These results highlight HTD1801’s potential for sustained glucose metabolism improvement.
Mechanism and Safety Profile
HTD1801 is an oral anti-inflammatory and metabolic modulator designed to treat metabolic and digestive system diseases. Beyond improving glycemic control, the drug demonstrated reductions in inflammatory markers closely associated with cardiovascular events in T2DM patients, including glutamyl transferase (GGT) and high-sensitivity C-reactive protein (hsCRP). HTD1801 also exhibited a favorable safety and tolerability profile, with no significant risk of hypoglycemia, addressing a critical concern in diabetes management.
Market Implications
The positive data from the SYMPHONY studies position HTD1801 as a promising new therapy for T2DM patients, particularly those with unmet needs in glycemic control. HighTide Therapeutics plans to submit an NDA in China this year, marking a significant step toward bringing this innovative treatment to market and potentially reshaping the landscape of diabetes care.-Fineline Info & Tech