September 10, 2021
SHENZHEN, CHINA and ROCKVILLE, MD, September 13, 2021 — HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, announced that the first group of patients have been enrolled and dosed in a PK bridging study of HTD1801in China.
The bridging study will evaluate the safety, tolerability and pharmacokinetic (PK) parameters of HTD1801 in 24 healthy Chinese subjects, as a step to accelerate HTD1801’s clinical trials for the treatment of Type 2 Diabetes Milletus (T2DM) and other metabolic diseases in China.
Recent Phase II trials of HTD1801 in primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH) comorbid with T2DM met the primary endpoint and several important secondary endpoints. This May, HighTide received approval from China’s Center for Drug Evaluation, National Medical Products Administration (CDE/NMPA) to conduct clinical trials in China with HTD1801 to improve blood glucose control in patients with T2DM.
Dr. Liping Liu, Founder and CEO of HighTide, commented: “Metabolic and digestive system diseases have complex pathophysiology and are often accompanied by multiple organ comorbidities. This complexity suggests that clinical treatment needs to consider the overall benefits of patients. In the face of increasing unmet clinical needs, we are very much looking forward to the HTD1801 clinical trials in China to provide patients with more effective treatment options.”
Diabetes is one of the fastest growing health problems in the 21st century. China has the world's largest population of diabetics, most of which are type 2 diabetes, and the number is increasing annually. According to the "Expert Consensus on the Management of Type 2 Diabetes and Nonalcoholic Fatty Liver in Adults in China" published in July 2021, about 49%-62% of patients with type 2 diabetes are associated with nonalcoholic fatty liver disease (NAFLD). There are nearly 70 million patients in China that have type 2 diabetes and nonalcoholic fatty liver disease (T2DM+NAFLD). The prognosis of these patients is generally poor. Compared with ordinary type 2 diabetes patients, the risks of cardiovascular disease, cardiovascular death and chronic kidney disease in type 2 diabetes patients with nonalcoholic fatty liver disease are 1.96, 3.46 and 1.87 times respectively. For such patients, more attention needs to be paid to comprehensive metabolic improvement and cardiovascular risk management.
HTD1801 has been shown in completed clinical studies to improve glucose and lipid metabolism, reduce weight, reduce liver fat, and improve liver function. It has the potential to bring comprehensive therapeutic benefits to patients with T2DM+NAFLD. HighTide will pay great attention to the therapeutic benefits of such patients in the following clinical development in China.
HTD1801 is a first-in-class new molecular entity being developed for the treatment of PSC, primary biliary cholangitis (PBC), nonalcoholic steatohepatitis comorbid with type 2 diabetes mellitus (NASH & T2DM), and T2DM comorbid with nonalcoholic fatty liver disease (T2DM & NAFLD).
HTD1801 has received Fast Track designation from the US FDA for both PSC and NASH, 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 additional information, please visit https://hightidetx.com.
About HighTide Therapeutics
HighTide Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutics for gastrointestinal diseases and metabolic disorders, with a focus on areas of high unmet medical need and lack of effective treatment options.