HighTide phase 2a Study of HTD1801 in NASH Patients meets primary endpoint

HighTide Therapeutics said that its HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes, as HTD1801 demonstrated broad beneficial effects in measures of glycemic control, liver injury and cardiovascular risk factors. The article was edited with a comment from Jeffrey Dao, Operating Officer & Business Development Officer. 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.  Stephen A. Harrison, M.D., Medical Director at Pinnacle Clinical Research, the principal investigator was very gratified with the study results. He said: “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, said: “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. In an email to Pharmaceutical Daily, Jeffrey Dao, Operating Officer & Business Development Officer said that in parallel, the company expects to complete a Phase 2 in primary sclerosing cholangitis in the U.S. and Canada, with topline results in 2H2020. “Given the safety profile and beneficial effects of HTD1801, we see great potential for these indications, and anticipate exploration of other indications as well,” he told Pharmaceutical Daily.