China-based HighTide Therapeutics Inc. (HKG: 2511) has announced that its Phase II study for the drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) as a treatment for type 2 diabetes (T2DM) has achieved its primary endpoint and several important secondary endpoints. The study demonstrated that treatment with HTD1801 resulted in a superior reduction in glycosylated hemoglobin (HbA1c) from baseline compared to the placebo group, and the drug was well-tolerated.
HTD1801: A Potential First-in-Class Treatment for Multiple Indications
HTD1801 is a potential global first-in-class new molecular entity under development to treat primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), non-alcoholic steatohepatitis (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 and is expected to become the first PSC therapy globally.
Advancing HTD1801 into Phase III Clinical Trials
In February of last year, HighTide reached a consensus with the US FDA to advance HTD1801 into a Phase III multi-regional clinical trial (MRCT). This decision followed shortly after the enrollment of the first patient in a Phase II study for the drug in type 2 diabetes two months prior.
Significant Unmet Clinical Need for T2DM and NAFLD Treatment
Epidemiological data indicate that 50%-60% of T2DM patients also have non-alcoholic fatty liver disease (NAFLD). There remains a significant unmet clinical need for the treatment of patients with T2DM and NAFLD, highlighting the potential impact of HTD1801’s development on these patient populations.-Fineline Info & Tech
