This study met the primary endpoint and multiple key secondary endpoints, demonstrating the safety and efficacy of HTD1801 in treating PSC. Serum alkaline phosphatase (ALP) is a key biomarker of PSC disease severity. Data show that compared to placebo, both low and high doses of HTD1801 treatment could significantly reduce serum ALP levels. In addition, HTD1801 significantly reduced alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT), further supporting the beneficial effects of HTD1801 in treating PSC. HTD1801 was shown to be safe and well tolerated at the doses studied in PSC patients. No severe adverse event related to HTD1801 treatment occurred.
Professor Kris Kowdley, M.D., Director, Liver Institute Northwest and lead investigator, said, “There is a significant unmet medical need in treatment for PSC. The improvements in ALP we observed in this study, along with the excellent safety profile of HTD1801, are promising. In addition, the results of this study lay the foundation for future studies that will potentially prove the significant role of HTD1801 in the treatment of PSC.”
Dr. Liping Liu, Founder and Chief Executive Officer of HighTide Therapeutics, said, “We are pleased to share the news of this publication. The results of this study encourage us to further study HTD1801’s effects in treating PSC. We believe the long-term treatment of HTD1801 will lead to more clinical benefits for patients with PSC, who suffer with a disease with no effective therapy until today.”
About Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by progressive inflammation and fibrosis of the intra-and/or extra-hepatic bile ducts, resulting in multifocal bile duct strictures. Most patients eventually have liver failure and cirrhosis, and their risk of malignancy significantly increases. PSC is strongly associated with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease. The accumulating evidence from various studies continues to strengthen the hypothesis that the gut microbiota plays a central role in the pathogenesis and progression of PSC. Until today, there is no approved therapy for PSC. As the fifth leading indication for liver transplantation in the U.S., PSC is a disease with significant unmet medical needs.
About HighTide Therapeutics
HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has 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. For more information, please visit www.hightidetx.com.
American Journal of Gastroenterology
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