SHENZHEN, China & ROCKVILLE, Md. – HighTide Therapeutics (“HighTide”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for non-viral chronic liver diseases, gastrointestinal diseases, and metabolic disorders, today announced that the first patient has been dosed in HighTide’s Phase 2 PRONTO-PBC study evaluating first-in-class HTD1801 in adult patients with primary biliary cholangitis (PBC).
The objectives of this open label study is to evaluate the safety and efficacy of HTD1801 in patients with PBC who have an inadequate response to ursodeoxycholic acid, the standard of care. The primary endpoint is change in serum alkaline phosphatase, a surrogate biomarker of cholestasis in PBC. Secondary endpoints include change in additional serum markers of cholestasis, markers of other liver function, markers of liver fibrosis and lipids. The study will enroll up to 30 patients in the United States.
“With the effective prevention and treatment of viral hepatitis such as hepatitis B and C, non-viral chronic liver diseases such as cholestatic liver disease and fatty liver have become the main causes of liver cirrhosis, liver cancer, and liver transplantation, which seriously endanger human health,” said Liping Liu, Ph.D., Founder and CEO of HighTide Therapeutics. “Following the promising results of Phase 2 trials of HTD1801 in primary sclerosing cholangitis (PSC) and non-alcoholic steatohepatitis (NASH), we are pleased to start this clinical trial in another patient population in need of better treatment options. Initiation of this study is an important milestone for our PBC development program.”
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, chronic inflammatory disease characterized by impaired bile flow (cholestasis) and the accumulation of toxic bile acids in the liver. There is an accompanying inflammation and destruction of the intrahepatic bile ducts which, unless treated, progress to liver fibrosis, cirrhosis and ultimately liver failure. Common symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC generally develops around the ages of 40-60 years, with women more commonly affected than men.
About HighTide Therapeutics
HighTide Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutics for non-viral chronic liver diseases, gastrointestinal diseases and metabolic disorders, with a focus on areas of high unmet medical need and lack of effective treatment options.
HTD1801 is a first-in-class new molecular entity being developed for the treatment of PSC, PBC, NASH comorbid with Type 2 Diabetes Mellitus (NASH & T2DM), and T2DM/NAFLD.
Phase II trials of HTD1801 in PSC and NASH comorbid with T2DM met the primary endpoint and several important secondary endpoints. Recently, HTD1801 has been approved by China’s Center for Drug Evaluation, National Medical Products Administration (CDE/NMPA) to conduct clinical trials in China to improve blood glucose control in patients with T2DM.
HTD1801 has received Fast Track designation from the U.S. FDA for both PSC and NASH, as well as Orphan Drug designation for PSC. In China, HTD1801 has been incorporated in China’s Major New Drug Innovation Program under the 13th Five-year Plan for Major Technology Project. For additional information, please visit https://hightidetx.com.