ROCKVILLE, MD and SHENZHEN, CHINA, November 2, 2023—HighTide Therapeutics, Inc. (“HighTide”), a globally integrated biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for metabolic and digestive diseases, announces dosing of the first patient in Hong Kong, at the Prince of Wales Hospital, as part of an ongoing multi-regional Phase 2b clinical study (the CENTRICITY study) evaluating berberine ursodeoxycholate (HTD1801) for the treatment of nonalcoholic steatohepatitis (NASH). Professor Vincent WS Wong serves as Principal Investigator at the Prince of Wales Hospital in Hong Kong.

This double-blind, randomized, placebo-controlled, multicenter, multi-regional Phase 2b   study evaluates the effect of HTD1801 on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus (T2DM) or pre-diabetes. The study plans to enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive HTD1801 or placebo for up to 60 weeks.

“Dosing of the first patient in Hong Kong in our ongoing study marks a key milestone in the development of HTD1801 for the treatment of NASH,” said Dr. Leigh MacConell, Chief Development Officer of HighTide. “Given the prior success of our Phase 2a study of HTD1801 in NASH and Phase 2 study of HTD1801 in T2DM in China, we believe the therapeutic potential of HTD1801 as a treatment for patients with NASH and comorbid T2DM or pre-diabetes represents a global development opportunity.”

“As an important component of the ongoing NASH trial, we are fully committed to advancing the clinical development of HTD1801 in anticipation of bringing safer and more effective treatment options to patients and physicians in the future,” said Prof. Vincent WS Wong, M.D., Principal Investigator of the CENTRICITY trial at the Prince of Wales Hospital, Hong Kong.

About NASH

NASH is a severe progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis that can lead to cirrhosis, liver failure, cancer, and death. Patients with NASH and T2DM or impaired glucose tolerance are more likely to progress to more severe disease and to develop complications that lead to increased mortality. Prevalence of NASH is on the rise and is the fastest growing cause of liver transplants and liver cancer in the US and Europe. Currently, there are no approved therapies for NASH.

About HighTide Therapeutics

HighTide Therapeutics, Inc. is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted 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). 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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