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HighTide Therapeutics Announces First Patient Dosed in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus

April 28, 2022

SHENZHEN, CHINA and ROCKVILLE, MD, April 28, 2022 — HighTide Therapeutics, Inc. (“HighTide”), a globally integrated clinical-stage biotechnology company developing drugs with multi-functional biological actions to address the complex pathophysiology of metabolic and digestive diseases, announced that the first patient was dosed in a phase 2 study evaluating HTD1801 in patients with type 2 diabetes mellitus (T2DM) in China.

The objective of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of HTD1801 in 99 adult subjects with T2DM, with a specific focus on the therapeutic effects of HTD1801 on patients with comorbid type 2 diabetes mellitus and nonalcoholic fatty liver disease (T2DM+NAFLD). The primary endpoint is the change in hemoglobin A1c (HbA1c) after 12 weeks of treatment, and secondary endpoints include changes in markers of NAFLD, liver function, and metabolic parameters.

“Following the positive phase 2 study results in adults with comorbid nonalcoholic steatohepatitis (NASH) and T2DM in the United States, we are excited to initiate this clinical study in T2DM patients in China, focusing on the T2DM+NAFLD subgroup,” said Liping Liu, Ph.D., Founder and CEO of HighTide Therapeutics.

About Comorbid Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (T2DM+NAFLD)

T2DM and NAFLD remain the most common chronic diseases worldwide with rapidly increasing prevalence and incidence. T2DM and NAFLD are closely linked—T2DM promotes the progression of NAFLD to NASH and increases the risk of progression to cirrhosis and hepatocellular carcinoma, while NAFLD is associated with an increased risk of developing insulin resistance and T2DM. Both diseases associate with an increased risk of cardiovascular disease. Given the strong association and overlapping pathophysiology, there is a sizable population of patients with comorbid T2DM and NAFLD. In China, there are more than 70 million patients with T2DM+NAFLD.

The complex pathophysiology of T2DM and NAFLD requires the engagement of multiple mechanistic pathways to optimize pharmacological intervention. HTD1801 is a first-in-class new molecular entity with pleiotropic effects, designed to target both the metabolic pathways critical to the development of T2DM and pathogenic factors underlying liver dysfunction and the progression of NAFLD.

About HighTide Therapeutics

HighTide is a globally integrated clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat metabolic and digestive diseases with significant unmet medical need. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity being developed for the treatment of primary sclerosing cholangitis, primary biliary cholangitis, NASH with comorbid T2DM and pre-T2DM, T2DM with comorbid NAFLD, and hypertriglyceridemia.

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Jeffrey Dao


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