HighTide Therapeutics receives fast track designation for NASH treatment

HighTide Therapeutics received FDA fast track designation for its investigational drug HTD1801 for the treatment of patients with nonalcoholic steatohepatitis, according to a press release.

“At the recent AASLD Liver Meeting, experts in the field generally agreed that modest clinical responses to date are likely to be improved by thoughtful combination approaches,” Liping Liu, PhD, CEO of HighTide, said in the release. “HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia. We are pleased by the FDA's decision and look forward to bringing this much needed solution to millions of patients suffering from this disease.”

HighTide completed its first human study of HTD1801 in healthy volunteers.

The company also announced plans to begin enrollment for a phase 2 trial in patients diagnosed with NASH from multiple centers. A multicenter phase 2 trial in adult patients with PSC is currently ongoing in the United States.

“This represents another step forward in our development of HTD1801 for the treatment of liver diseases with no currently approved therapies,” Janice Soreth, MD, chief strategy and regulatory officer of HighTide, said in the release. “We are proceeding with parallel clinical development of HTD1801 for NASH as well as primary sclerosing cholangitis (PSC) for which HTD1801 already received orphan drug designation and fast track designation.”

Reference: www.hightidebio.com