December 21, 2020
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 and ROCKVILLE, MD,December 15, 2020— HighTide Therapeutics Inc. (“HighTide”), a clinical-stage biopharmaceutical company with novel treatments for patients with non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that Adrian M. Di Bisceglie, Chief Medical Officer, will present at the digital 4th Annual NASH Summit on Wednesday, December 16, 2020 at 3pm EST.
HighTide will show the results of their Phase 2 study of HTD1801 in adults with non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM). The study was a dose-ranging, double blind, placebo controlled, multi-center clinical trial evaluating the treatment effects of HTD1801. The study met the primary endpoint (absolute liver fat reduction) and several important metabolic secondary endpoints, in a dose-responsive manner. Subjects received either HTD1801 500mg BID (n=33), 1,000mg BID (n=34) or placebo (n=33) for 18 weeks. Subjects receiving the 1,000mg BID dose had a mean absolute liver fat content decrease from baseline of 4.83% (p=0.011 vs. placebo); and mean relative liver fat reduction of 24.14% (p=0.016 vs. placebo), as measured by MRI-PDFF. Treatment with HTD1801 for 18 weeks also resulted in robust reductions in markers associated with glycemic control and liver injury: mean hemoglobin A1c (HbA1c) level decreased from 7.4 (baseline) to 6.8 (week 18) (p=0.004); alanine aminotransferase (ALT) reduced 19 U/L (p=0.007), greater than the 17 U/L threshold that has been correlated with histologic improvement in NASH; and gamma glutamyl transferase (GGT) reduced 29 U/L (p<0.001), suggesting a reduction in hepatocellular oxidative stress. HTD1801 was generally well tolerated and no unexpected side effects were noted with its use.
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
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 is a new molecular entity being developed for the treatment of NASH, PSC and PBC. 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/.