November 19, 2019
Approvals Support Clinical Trials in China and Canada
for HTD1801 in Primary Sclerosing Cholangitis
SHENZHEN, CHINA and ROCKVILLE, MD, November 19, 2019 — HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, today announced that it has received investigational new drug (IND) application approval from the National Medical Products Administration of China, and also a No Objection Letter (NOL) from Health Canada, for HTD1801. These regulatory milestones support the Company’s plans to initiate proof of concept clinical trials of HTD1801 for primary sclerosing cholangitis (PSC) outside the U.S.
“These two regulatory approvals are part of our plan to increase the number of countries in which we conduct clinical trials of HTD1801 for PSC, and reflect HighTide’s plans to help patients on a global scale,” said Liping Liu, Ph.D., Founder and Chief Executive Officer of HighTide. “We would like to thank the thought-leading investigators in China and Canada who have to date expressed interest in helping us conduct these studies.”
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.
About HighTide Therapeutics
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 www.hightidetx.com.