SHENZHEN, CHINA and ROCKVILLE, MD, October 22, 2019 — HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, today announced that the last patient has been enrolled in A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM. This trial is a double blind, placebo controlled, multi-center Phase 2a clinical trial evaluating the treatment effects of HTD1801 compared with placebo in adult nonalcoholic steatohepatitis (NASH) patients with type 2 diabetes mellitus (T2DM).
“We would like to thank the investigators who have collaborated with us on this study. We look forward to sharing the findings from this trial in early 2020,” said Liping Liu, Ph.D., Founder and Chief Executive Officer of HighTide. “We are excited to move this potential new therapy one step closer to the large number of NASH patients who are in urgent need of new treatment options.”
About The Phase 2a Study
This Phase 2a proof-of-concept study has enrolled 100 patients at seventeen centers in the U.S. NASH patients with T2DM have been randomized to receive either a 500mg or 1,000mg BID dose of HTD1801 or placebo for 18-weeks. The primary endpoint, absolute reduction in liver fat content, will be evaluated by MRI-PDFF. Secondary endpoints include relative reduction in liver fat content, as well as markers associated with liver function, fibrosis, cholesterol, and total bile acids.
NASH, a form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis – inflammation of the liver – and liver cell damage, which can lead to fibrosis of the liver. NASH can also lead to cirrhosis and liver cancer. Prevalence of NASH is on the rise and may soon surpass hepatitis C as a cause for liver transplant in the U.S. and Europe. Currently, there are no approved therapies for NASH.
About HighTide Therapeutics and HTD1801
HighTide Therapeutics Inc., founded in 2011 in Shenzhen, China, is dedicated to the discovery and development of innovative therapeutics for people suffering from non-viral chronic liver diseases, gastrointestinal diseases and metabolic disorders with large and unsatisfied market needs. HTD1801, HighTide’s lead program, is a new molecular entity being developed for the treatment of NASH and 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. HTD1801 is currently in Phase 2 proof of concept trials for NASH and PSC in the U.S. with topline data expected in 2020. HighTide also has compounds in development for metabolic and GI diseases, including HTD4010 for Pancreatitis. For additional information, please visit https://hightidetx.com/.
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 disease deteriorates to fibrosis, cirrhosis and ultimately liver failure, with an increased risk of malignancy. Currently, there are no approved therapies for PSC.