SHENZHEN, China & ROCKVILLE, Md.--(BUSINESS WIRE)--HighTide Therapeutics, Inc. (“HighTide”), a clinical-stage biopharmaceutical company developing treatments for chronic liver / gastrointestinal diseases and metabolic disorders, today announced that the company and U.S. Food and Drug Administration (FDA) reached agreement to proceed to Phase 3 development of HTD1801 for the treatment of primary sclerosing cholangitis (PSC). The company had a productive discussion with FDA as part of an End-of-Phase 2 meeting, regarding the key elements of the study design and will be submitting a Phase 3 protocol to FDA for review and comment.
As previously announced, the company completed a Phase 2 study of HTD1801 in patients with PSC. This dose-ranging, double-blind, placebo-controlled Phase 2 clinical trial evaluated the treatment effects of HTD1801 in 55 adult patients with PSC conducted at over 20 clinical sites in the U.S. and Canada. The study met the primary efficacy endpoint (change in serum levels of alkaline phosphatase, or ALP), with statistically significant reductions in both the 500mg BID (p=0.0160) and 1000mg BID (p=0.0194) HTD1801 dose groups after 6 weeks compared to placebo. Serum levels of gamma-glutamyl transferase, alanine aminotransferase, and aspartate aminotransferase also were reduced with both doses of HTD1801 compared with placebo. HTD1801 was generally well tolerated and no serious adverse events attributable to the study drug were noted.
“We would like to acknowledge the helpful guidance that FDA has provided,” said Liping Liu, Ph.D., Chief Executive Officer of HighTide. “We look forward to continuing our collaborative dialogue throughout the Phase 3 development of HTD1801 for PSC, and bringing a solution to patients who still have no approved therapy.”
HighTide is a global clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat chronic liver / gastrointestinal diseases and metabolic disorders with high unmet medical need. The company’s lead drug candidate, HTD1801, is a potential first-in-class new molecular entity being developed for the treatment of PSC, primary biliary cholangitis, nonalcoholic steatohepatitis comorbid with type 2 diabetes mellitus (T2DM) and pre-T2DM (NASH + T2DM/pre-T2DM), and T2DM comorbid with nonalcoholic fatty liver disease (T2DM + NAFLD), and severe hypertriglyceridemia.
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