source from：Endpoints News

Liping Liu, HighTide Therapeutics CEO

HighTide Therapeutics has raised a $107 million Series C round to fund mid-stage studies in metabolic and digestive diseases, with the goal of filing for approval in China within two to three years.

HighTide, which has roots in Shenzhen, China, and Maryland, disclosed the round Thursday morning in advance of the JPMorgan healthcare meeting. CEO and founder Liping Liu told Endpoints News the financing would likely bankroll the company into the 2024 to 2025 timeframe.

HighTide’s main asset is HTD1801. The oral drug contains ionic salt of two active moieties: berberine, an over-the-counter drug in China used for gastrointestinal infections; and ursodeoxycholic acid, which is used in treating certain liver diseases and is being tested as a tool to protect people from future variants of the Covid-19 pandemic.

“We really see the 1+1 greater than 2 synergistic effect,” Liu said of the combination.

In China, the focus is on Type II diabetes, with a Phase II near completion and a Phase III on the horizon, Liu said. HighTide eyes seeking regulatory approval in China in the 2025-2026 timeframe, she added.

In the US, HighTide has its sights set on NASH, with a Phase IIb study underway as of the last week of 2022. The trial is expected to collect final primary outcome data on the last day of 2024, according to an update this week to a US government clinical trials database. The biotech is also discussing a Phase III protocol with the FDA to test HTD1801 in patients with primary sclerosing cholangitis, a chronic liver disease for which there are no approved drugs, Liu said.

Fast track status has been granted to HTD1801 for both of those indications.

The R&D field for NASH, or non-alcoholic steatohepatitis, has seen a resurgence in the past four months with wins at Madrigal, Akero and Chemomab. But, citing the expense of running a Phase III in one of the most failure-prone areas in biotech, Chemomab won’t continue in NASH unless it finds a partner, it said this week. Intercept also resubmitted its NDA for obeticholic acid last week after a 2020 rejection.

Liu expects the field to have approved NASH drugs in the coming years, and more will follow in the footsteps of Intercept and Madrigal. The space is “coming out from the muddy times and it’s going to get better,” she said.

HighTide previously raised a $60 million Series B in late 2020. Investors include TCM Healthcare Fund, Yuexiu Fund and Yuthai Fund.