HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, today announced the topline results of the study of HTD1801 in primary sclerosing cholangitis (PSC) will be presented at the International Liver Congress 2021, 23-26 June. This trial was a dose-ranging, double blind, placebo controlled, multi-center Phase 2 clinical trial evaluating the treatment effects of HTD1801 in 55 adult patients with PSC conducted at 25 clinical sites in the US and Canada.
Subjects received either HTD1801 500mg, 1000mg or placebo BID for 6 weeks, followed by a dose extension period for 6 weeks and a randomized withdrawal period of 6 weeks. The study met the primary endpoint (change in serum levels of alkaline phosphatase) in a dose responsive manner, with statistically significant reductions in the 500mg BID (p=0.016) and 1000mg BID (p=0.019) dose of HTD1801 after 6 weeks compared to placebo. HTD1801 was generally well tolerated and no unexpected side effects were noted.
“I am very pleased by these results,” said study principal investigator, Kris Kowdley, M.D., Director at Liver Institute Northwest. “The finding that HTD1801 significantly reduces alkaline phosphatase shows that HTD1801 has activity in this difficult to treat disease and provides a basis for further study of this well-tolerated agent in PSC. I look forward to continued collaboration with HighTide in the next steps of HTD1801 development.”
Adrian M. Di Bisceglie, M.D., Chief Medical Officer of HighTide, said, “Even though study enrollment was limited by the COVID pandemic, we were able to successfully complete the trial, with positive results that clearly justify further exploration of HTD1801 in PSC. We would like to thank the investigators, clinical site staff, and patients who participated in this study during these challenging circumstances.”
“PSC is a disease that still lacks an approved therapy,” added Liping Liu, Ph.D., Founder and CEO of HighTide. “Based on the data from this Phase 2 trial, we are encouraged to see that there is potential to offer patients a solution.”
Primary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by inflammation and fibrosis of the bile ducts, leading to the formation of multifocal bile duct strictures. This cholestatic liver disease often leads to fibrosis, cirrhosis and ultimately liver failure, with an increased risk of malignancy. Currently, there are no approved therapies for PSC.
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, primary biliary cholangitis (PBC), nonalcoholic steatohepatitis comorbid with type 2 diabetes mellitus (NASH + T2DM), and T2DM comorbid with nonalcoholic fatty liver disease (T2DM & NAFLD).
A Phase II trial of HTD1801 in PSC and NASH comorbid with T2DM met the primary endpoint and several important secondary endpoints. Recently, HighTide has been approved by 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.
HTD1801 has received Fast Track designation from the US FDA for both PSC and NASH, as well as Orphan Drug designation for PSC. For additional information, please visit https://hightidetx.com.
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