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HighTide Therapeutics Announces Early Completion of Enrollment in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus

August 30, 2022

SHENZHEN, CHINA and ROCKVILLE, MD, August 30, 2022 — HighTide Therapeutics, Inc. (“HighTide”), a globally integrated clinical-stage biotechnology company focused on the development of innovative multi-functional therapeutics to address the complex pathophysiology of metabolic and digestive diseases, announced that enrollment was completed ahead of schedule in a Phase 2 study evaluating HTD1801 in patients with type 2 diabetes mellitus (T2DM) in China. 

Led by Professor Linong Ji, Director of the Department of Endocrinology at Peking University People’s Hospital, this multi-center, randomized, double-blind, placebo-controlled study aims to evaluate the safety and efficacy of HTD1801 in adult subjects with T2DM, with a specific focus in patients with comorbid T2DM and nonalcoholic fatty liver disease (T2DM+NAFLD). The study enrolled 113 subjects, and the endpoints include the change in hemoglobin A1c (HbA1c) after 12 weeks of treatment as well as changes in biomarkers of NAFLD. 

“The unique design of HTD1801 results in its pleiotropic therapeutic effects. Previous Phase 2 study in adults with comorbid nonalcoholic steatohepatitis (NASH) and T2DM completed in the United States demonstrated overall clinical benefits across liver, lipid, glycemia, weight, metabolic, and cardiovascular health. For the ongoing T2DM trial in China, with the collective efforts from our patients, investigators, sites, and the HighTide team, we were able to complete enrollment ahead of time despite the COVID-19 pandemic. We are appreciative of the study participants and look forward to potentially providing T2DM patients, especially patients with comorbid T2DM and NAFLD, with a safe and effective therapeutic,” 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 are both common chronic diseases worldwide (prevalence as high as 9.3% and 25%-30%, respectively). The two indications not only share the same pathogenic factors but are also among each other’s common comorbidities, mutually increasing the risk of disease and accelerating disease progression. The strong bidirectional relationship between T2DM and NAFLD forms a large comorbid patient population with both T2DM and NAFLD (approximately 49%-62% T2DM patients also suffering from NAFLD; there are more than 70 million T2DM+NAFLD patients in China alone), and leads to worse prognosis among comorbid patients than patients with T2DM or NAFLD alone. These T2DM+NAFLD patients face more challenges to achieve glycemic control, are more likely to progress to severe liver diseases (e.g., NASH, liver cirrhosis, hepatocellular carcinoma), are at greater risk of developing fatal complications (e.g., cardiovascular disease, kidney disease), and have a higher risk of mortality (the leading cause of death is cardiovascular disease).

For the treatment of T2DM+NAFLD, the "Management of Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease: an expert consensus" published by the Chinese Society of Endocrinology and Chinese Diabetes Society in 2021 clearly emphasizes the treatment goals of T2DM+NAFLD, i.e., on the basis of controlling the progression of both T2DM and NAFLD, to simultaneously control other risk factors of cardiovascular disease (such as obesity, hypertension, dyslipidemia, hyperuricemia, etc.), as well as to prevent, diagnose, and treat diabetes-related target organ damage and adverse outcome of liver.

The multi-functional HTD1801 developed by HighTide aims to provide patients with broad clinical benefit across glycemia, liver, and cardiovascular health. The company expects HTD1801 to become the essential drug for the treatment of T2DM+NAFLD, providing an innovative solution with a good safety profile and comprehensive benefits for T2DM+NAFLD patients.

About HighTide Therapeutics

HighTide is a globally integrated clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class multi-functional drugs for metabolic and digestive diseases with significant unmet medical needs.

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Jeffrey Dao


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