HighTide Therapeutics Presents Phase 2a MASH Study Analyses at 2024 International Liver Congress, Highlighting Efficacy and Safety of HTD1801

HighTide Therapeutics, Inc., a clinical stage biopharmaceutical firm with a focus on developing multi-targeted treatments for chronic liver and metabolic diseases, announced its participation in the European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5-8, 2024. The company will present several post-hoc analyses from its Phase 2a clinical study of berberine ursodeoxycholate (HTD1801) in patients suffering from metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM).

The Chief Development Officer of HighTide, Dr. Leigh MacConell, stated that the ongoing multi-regional Phase 2b study, CENTRICITY, is fully enrolled and will evaluate the histologic benefits of HTD1801 in the same patient population. The results are expected in the first half of 2025.

One of the presentations, titled "Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM" (Abstract SAT-227), highlights a comparative efficacy analysis of ongoing GLP-1 Receptor Agonist (GLP-1RA) treatment versus newly initiated HTD1801 therapy. The findings suggest that HTD1801 offers greater benefits across several cardiometabolic endpoints compared to ongoing GLP-1RA use. This is significant for patients with MASH and T2DM already on GLP-1RA treatment, as HTD1801 may provide additional glucose and lipid lowering, as well as weight loss benefits.

Another presentation, "Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance" (Abstract SAT-225), focused on addressing insulin resistance—a critical risk factor for T2DM, obesity, and MASH. HTD1801 improves insulin sensitivity by enhancing the utilization of glucose and fats through the activation of AMP-activated protein kinase (AMPK). The post-hoc analysis showed that HTD1801 alleviates the metabolic inhibitory effects of hyperinsulinemia, offering potentially greater metabolic benefits for patients with more severe insulin resistance.

A third presentation titled "Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM" (Abstract SAT-243) examined the gastrointestinal (GI) adverse events (AEs) associated with HTD1801. The most frequently occurring GI AEs were diarrhea and nausea, which were generally mild to moderate in severity and showed a decreasing trend in incidence and prevalence over the treatment course. These findings suggest that HTD1801’s GI tolerability improves with continued use, supporting its potential for long-term treatment of chronic diseases like MASH.

HighTide Therapeutics, headquartered in Rockville, MD, and Shenzhen, China, is dedicated to discovering and developing first-in-class multifunctional, multi-targeted therapies for chronic liver and metabolic diseases that have significant unmet medical needs. The company’s leading candidate, HTD1801, has received Fast Track designation from the U.S. FDA for both NASH and primary sclerosing cholangitis (PSC) and Orphan Drug designation for PSC. Additionally, HTD1801 has been included in China’s National Major New Drug Innovation Program.

HighTide Therapeutics continues to advance its clinical programs, aiming to offer novel therapeutic options for complex metabolic and liver diseases.