ROCKVILLE, MD and SHENZHEN, CHINA, October 3rd, 2023— HighTide Therapeutics, Inc. (“HighTide”) announces that the primary findings from the Phase 2 clinical trial of berberine ursodeoxycholate (HTD1801), a first-in-class gut-liver anti-inflammatory metabolic modulator for patients with type 2 diabetes mellitus (T2DM), will be presented as oral presentation (# 632) at the 59th Annual Meeting of the European Association for the Study of the Diabetes (EASD), held October 2-6, 2023 in Hamburg, Germany.

Berberine Ursodeoxycholate (HTD1801) Improves Glycemic Control in Patients with Type 2 Diabetes: Double-Blind, Placebo-Controlled, Phase 2 Study

Abstract Number: # 632
Presentation Type: Oral
Date and Time: Tuesday, October 3, 2023, 12:30 -13:30 PM (CEST)
Presenter: Professor Linong Ji, Director of Peking University Diabetes Center, and Director of the Department of Endocrinology and Metabolism of Peking University People's Hospital.

This trial was a 12-week randomized, double-blind, placebo-controlled, Phase 2 study designed to evaluate the efficacy and safety of HTD1801 compared to placebo in treatment-naive adult patients with T2DM. One hundred and thirteen patients were randomized into 3 treatment groups: one of two doses of HTD1801 (500 mg BID and 1000 mg BID) or placebo. The study met the primary endpoint (reduction of Hemoglobin A1c [HbA1c]) and achieved clinically important secondary endpoints related to improvements in metabolic and glycemic control. After 12 weeks of treatment, there was a significant reduction in HbA1c with HTD1801 1000 mg BID treatment (LS mean change: -1.0%). Furthermore, a larger proportion of subjects receiving HTD1801 1000 mg BID compared to placebo achieved HbA1c <7% (55.9% vs 15.2%) and <6.5% (29.4% vs 6.1%). HTD1801 treatment resulted in significant improvements in measures of hepatic inflammation and damage (alanine transaminase [ALT], aspartate transaminase [AST] and gamma-glutamyl transpeptidase [GGT]), particularly relevant with the risk and frequent overlap of metabolic-dysfunction associated steatotic liver disease (MASLD) in patients with T2DM. HTD1801 was generally safe and well tolerated. These data provide further evidence that HTD1801 broadly improves key measures of metabolic and glycemic control.

“T2DM patients often have multiple metabolic comorbidities associated, therefore new strategies on glycemic control needs to be considered in conjunction with the management of other risk factors. This Phase 2 study result indicates that HTD1801 significantly lowers blood glucose levels and demonstrates the potential in reducing other metabolic comorbidities such as lipids and liver transaminases. These findings suggest that HTD1801 may offer multiple benefits to patients with T2DM and could potentially become a new class of antidiabetic medication that could further benefit people with type 2 diabetes, warranting further development” said Prof. Linong Ji at EASD, M.D., a leading expert in T2DM and the principal investigator for the study.

“We are greatly encouraged by the observed improvements in glycemic control in this study, which continues to show the therapeutic potential of HTD1801 in patients with T2DM. Based on these data, we believe HTD1801 has the potential to play an important role in treating patients with metabolic diseases including T2DM. We are actively planning a phase 3 program to confirm our findings with an aim to provide T2DM patients a single agent offering multiple benefits.” said Dr. Liping Liu, Founder, and CEO of HighTide.

About HighTide
HighTide Therapeutics, Inc. is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multi-functional multitargeted therapies with poly-indications across metabolic and digestive diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). 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.

For more information, please visit www.hightidetx.com
Contact: pr@hightidetx.com.