Highlighting Benefits of Berberine Ursodeoxycholate (HTD1801)
HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, presents at the 60th European Association for the Study of Diabetes (EASD) Annual Meeting, taking place from September 10-13, 2024 in Madrid, Spain. The presentations include post-hoc analyses of two Phase 2 clinical studies of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with type 2 diabetes mellitus (T2DM).
“These data provide additional insight on the potential benefits of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with T2DM. The two ongoing Phase 3 studies (NCT06350890, NCT06415773), fully enrolled in 2Q 2024, evaluate the efficacy and safety of HTD1801 in T2DM patients (as monotherapy or in combination with metformin). We look forward to the results of these Phase 3 studies which we expect to announce in 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.
“Efficacy of Berberine Ursodeoxycholate (HTD1801) in Chinese and Western Patients with T2DM”
(Presentation 711, Oral Presentation, September 11, 12:45 PM CEST)
About the Abstract: T2DM and MASH are highly interrelated, the presence of each increasing risk of outcomes. Patients with both T2DM and MASH are at higher risk of histologic progression in MASH, cardiovascular outcomes, hepatic outcomes, and all-cause mortality. The purpose of this analysis was to compare the effects of HTD1801 in Chinese and Western patients with T2DM with or without MASH. These data demonstrate that while the two populations are ethnically distinct with related but different diseases, treatment with HTD1801 was associated with improvements in key measures of glycemic, cardiometabolic, and hepatic benefit in both populations. HTD1801 offers holistic benefits that are observed in both Chinese and Western patients, irrespective of underlying disease, that address core aspects of both T2DM and MASH.
“Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Diseases and Severe Insulin Resistance”
(Presentation 708, Oral Presentation, September 11, 12:45 PM CEST)
About the Abstract: Insulin resistance is a significant risk factor for T2DM, obesity and MASH. HTD1801 enhances the utilization of glucose and fats through activation of AMP-activated protein kinase (AMPK), thereby improving insulin sensitivity. As HTD1801 is under development as a treatment for patients with T2DM, as well as MASH, we analyzed the effects of HTD1801 response based on degree of insulin resistance. These data demonstrate that HTD1801 can alleviate the metabolic inhibitory effects caused by hyperinsulinemia, leading to even greater hepatic and metabolic benefits in patients with more severe insulin resistance, offering a unique therapeutic approach for individuals with T2DM and/or MASH.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (HKG: 2511) 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). 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.
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