Based on the successful Phase 2 study, two Phase 3 studies (NCT06350890, NCT06353347) are currently ongoing to further evaluate the efficacy and safety of HTD1801 (as monotherapy and as add-on to metformin) in patients with T2DM and inadequate control. “We look forward to the results of our pivotal T2DM program which we expect to announce in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters Across the T2DM Disease Spectrum” (Abstract 847-P, Poster Presented June 23rd)

About the Abstract:

In a Phase 2, placebo-controlled, double-blind study in patients with T2DM, treatment with HTD1801 for 12 weeks resulted in significant dose-dependent improvements in key glycemic parameters. The objective of this post-hoc analysis was to evaluate the effectiveness of HTD1801 in patients with T2DM across the disease spectrum based on baseline HbA1c, with a particular emphasis on glycemic and lipid metabolism markers, along with indicators of liver injury. These data show that regardless of baseline disease severity, HTD1801 treatment resulted in significant improvements across these key parameters. The magnitude of improvement was greater in those with more severe disease. HTD1801 may offer a unique therapeutic approach for individuals with T2DM and other comorbidities (i.e. MASH and dyslipidemia), as managing these conditions effectively is crucial in controlling T2DM and reducing its associated complications.

About HighTide Therapeutics

HighTide Therapeutics, Inc. (2511.HK) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

Disclaimer

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