ROCKVILLE, MD and SHENZHEN, CHINA, June 27, 2025—HighTide Therapeutics, Inc. (2511.HK), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, announced today that late-breaking data from the Phase 3 SYMPHONY 1 trial evaluating the safety and efficacy of berberine ursodeoxycholate (HTD1801) in patients with type 2 diabetes mellitus (T2DM) was presented at the American Diabetes Association’s (ADA) 85th Scientific Sessions Conference in Chicago.
This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of HTD1801 as monotherapy compared to placebo. The study met the primary endpoint with a significant and clinically meaningful reduction in HbA1c (-1.3%) with HTD1801 treatment. 42% of patients treated with HTD1801 achieved target HbA1c levels <7%. Beyond glucose control, significant improvements in lipid metabolism and inflammatory parameters were also observed, demonstrating the comprehensive benefits of HTD1801 monotherapy for the treatment of T2DM. HTD1801 was found to be safe and generally well tolerated.
Abstract Title: Symphony 1—A Randomized, Placebo-Controlled Phase 3 Study of Berberine Ursodeoxycholate as Monotherapy in Patients with Type 2 Diabetes
Abstract and Poster Number: 2001-LB
Format: Poster Presentation
Presenting Author: Linong Ji
“The SYMPHONY 1 results mark an exciting milestone in our mission to redefine the treatment landscape for type 2 diabetes,” said Liping Liu, Founder and CEO of HighTide Therapeutics. “HTD1801 was designed to address the complex interplay of metabolic dysfunction and inflammation, and these data move us one step closer to delivering a novel, multi-targeted therapy to patients worldwide. We look forward to sharing results from the open-label extension later this year.”
About Berberine Ursodeoxycholate
Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholic acid, is a new molecular entity with a unique dual mechanism of action: AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in insulin resistance, glucose metabolism, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases. HTD1801 is being developed for multiple indications. HTD1801 met the primary endpoint in two Phase 3 clinical trials in patients with type 2 diabetes mellitus (T2DM), demonstrating a clinically meaningful effect on HbA1c. In both trials, key secondary endpoints were achieved, suggesting multiple advantages of HTD1801 including improvement in cardiometabolic risk indicators. In addition to T2DM, HTD1801 efficacy in treating metabolic dysfunction-associated steatohepatitis (MASH) has been demonstrated in a Phase 2a clinical trial, and a global multicenter Phase 2b trial assessing the histologic benefit of HTD1801 is currently ongoing, with topline results expected in 2025.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (Stock Code: 2511.HK) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional, multi-targeted therapies with poly-indication potential across metabolic diseases with significant unmet medical needs. HighTide is currently developing several clinical assets and associated global intellectual property rights, and advancing multiple mid-to-late-stage clinical trials including therapies for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), HighTide’s lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China.
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