February 06, 2023
ROCKVILLE, MD and SHENZHEN, CHINA, February 6, 2023 — HighTide Therapeutics Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, announced that the Principal Investigator Meeting for the CENTRICITY study, a Phase 2b clinical study evaluating HTD1801 in nonalcoholic steatohepatitis (NASH) was held February 2-4, 2023. Principal investigators and their staff from leading research sites in the U.S. participated in the meeting to discuss the clinical trial.
This double-blind, randomized, placebo-controlled, multicenter Phase 2b study will evaluate the effect of HTD1801, 1250 mg twice daily (BID), compared to placebo BID on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus (“T2DM”) or pre-diabetes. The study will enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive HTD1801 for up to 60 weeks.
“Based on the positive results of the earlier HTD1801 Phase 2a clinical trial in NASH, we expect this study to show positive histopathologic benefit in those patients at greatest risk of disease progression (NASH with F2/3 fibrosis). We will focus on patients with the comorbid conditions of diabetes or pre-diabetes,” said Dr. Stephen Harrison, a leading expert in NASH and principal investigator for the study.
“We are pleased with the productive interactions with our collaborators to discuss the Phase 2b study design of HTD1801 in NASH patients,” said Dr. Leigh MacConell, Chief Development Officer of HighTide. “Dosing of patients has already initiated and we look forward to continued site activations and subject enrollment following this in-person meeting.”
NASH, asevere 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. NASH patients with T2DM or impaired glucose tolerance are more likely to progress to more severe disease and to develop complications that lead to increased mortality. Prevalence of NASH is on the rise and is surpassing hepatitis C as a cause for liver transplant in the U.S. and Europe. Currently, there are no approved therapies for NASH.
HighTide Therapeutics Inc. is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional therapies with poly-indications across metabolic and digestive diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). HTD1801, the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.
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