September 26, 2019
Based on Safety Data Review, DMC Recommends Continuing Trial
SHENZHEN, CHINA and ROCKVILLE, MD, September 26, 2019 — HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, today announced that the independent data monitoring committee (DMC) overseeing A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM (clinicaltrials.gov NCT03656744) has recommended continuing enrollment for the study.
“We are pleased to receive DMC approval to continue,” said Adrian M. Di Bisceglie, M.D.,Chief Medical Officer of HighTide. “This represents a key milestone and we look forward to sharing data from this POC trial of HTD1801 for treating patients with 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. For additional information, please visit https://hightidetx.com/.
HTD1801, HighTide’s lead program, is a new molecular entity being developed for the treatment of NASH and PSC. HTD1801 has received U.S. Food and Drug Administration Fast Track designation for both NASH and PSC, and FDA Orphan Drug designation for PSC. HTD1801 is currently in Phase 2 proof of concept trials for NASH and PSC in the U.S. Topline clinical results are expected in 2020.
In addition, HighTide has several other pipelines in development for GI and metabolic diseases, including HTD4010 for Pancreatitis.
Nonalcoholic steatohepatitis (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 lead to cirrhosis and liver cancer. Prevalence of NASH is on the rise and it may soon surpass hepatitis C as a cause for liver transplant. Currently, there are no approved therapies for NASH.
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.