HighTide Therapeutics Announces Positive Topline Results From Phase 2a Study of HTD1801 in NASH Patients

HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes

HTD1801 demonstrated broad beneficial effects in measures of glycemic control, liver injury and cardiovascular risk factors

SHENZHEN, China & ROCKVILLE, Md.--(BUSINESS WIRE)--HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company, today announced topline results of the study of HTD1801 in 100 adults with non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM). This trial was a dose-ranging, double blind, placebo controlled, multi-center Phase 2a clinical trial evaluating the treatment effects of HTD1801 in patients with NASH and T2DM conducted at 17 U.S. clinical sites.

The study met the primary endpoint (absolute liver fat reduction) and several important secondary endpoints including glycemic control and markers associated with liver injury in a dose-responsive manner. Subjects received either HTD1801 500mg, 1,000mg or placebo BID for 18 weeks. HTD1801 was generally well tolerated and no unexpected side effects were noted with its use. Further details will be presented at a forthcoming scientific meeting and via peer-reviewed publication.

“As the principal investigator, I was very gratified to see the study results,” said Stephen A. Harrison, M.D., Medical Director at Pinnacle Clinical Research. “The finding that HTD1801 significantly reduces liver fat content, HbA1c, serum ALT, and GGT levels, while being associated with a trend in decreases in serum lipids (LDL-C and TG) and weight loss, uniquely positions this as an orally-administered agent to be used by itself or in combination with other agents in the treatment of NASH associated with diabetes. I look forward to working with HighTide in the next steps of their development of HTD1801 and to the prospect of ultimately being able to use this agent clinically.”

Adrian D. Bisceglie, M.D., Chief Medical Officer of HighTide, said, “We would like to thank the investigators, clinical site staff, and especially the patients who participated in this study of HTD1801. We are excited by the totality of the study results.”

Liping Liu, Ph.D., Founder and Chief Executive Officer of HighTide, added, “Our decision to conduct this study specifically in NASH patients co-morbid with T2DM was based on the design of HTD1801 to address underlying metabolic processes which drive chronic diseases such as NASH. Estimates suggest there are over 11.5 million patients with NASH and T2DM in the U.S., so we believe this is a logical area of focus.”

Additionally, HighTide is also providing an update on the on-going Phase 2 study of HTD1801 in adult patients with primary sclerosing cholangitis (PSC) in the U.S. and Canada. Due to the impact of the COVID-19 pandemic, the Company has stopped enrollment of new participants while all active patients will continue treatment. Results are expected in 2H2020.

About NASH

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 PSC

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 and HTD1801

HighTide Therapeutics Inc. is dedicated to the development of innovative therapeutics for people suffering from non-viral chronic liver diseases, gastrointestinal diseases and metabolic disorders with large and unmet medical needs. HTD1801, berberine ursodeoxycholate, 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. For additional information, please visit https://hightidetx.com/.