Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a Phase IIb clinical study for its pipeline candidate HTD1801 in non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled study is designed to assess the histological improvement of HTD1801 compared with placebo in subjects with NASH and liver fibrosis, as well as type 2 diabetes (T2DM) or early-stage diabetes.
Study Design and Enrollment
The Phase IIb study aims to enroll approximately 210 adult subjects with NASH confirmed by biopsy and liver fibrosis in stage II or III. Participants will receive HTD1801 treatment for up to 60 weeks. This study builds on previous clinical work and aims to further evaluate the efficacy and safety of HTD1801 in this patient population.
Therapeutic Potential and Development
HTD1801 is a potential first-in-class new molecular entity being developed to treat primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), NASH comorbid with type 2 diabetes mellitus (NASH & T2DM), and T2DM comorbid with non-alcoholic fatty liver disease (T2DM & NAFLD). The drug has previously been awarded fast-track status and orphan drug designation (ODD) in the US, highlighting its potential to address significant unmet needs. HighTide reached a consensus with the US FDA to advance HTD1801 into a Phase III multi-regional clinical trial (MRCT) in February last year, with the first patient enrolled in a Phase II study for the drug in type 2 diabetes two months later.
Future Outlook
The initiation of the Phase IIb study for HTD1801 in NASH marks a significant milestone in HighTide Therapeutics’ development pipeline. With its potential to become the first PSC therapy globally, HTD1801 is poised to make a meaningful impact on patient outcomes in multiple liver diseases. HighTide’s ongoing clinical trials and regulatory progress underscore its commitment to advancing innovative treatments in hepatology.-Fineline Info & Tech
