Novel NASH Treatment Gets FDA’s Fast Track Designation

The Food and Drug Administration (FDA) has granted Fast Track designation to an investigational drug for the treatment of nonalcoholic steatohepatitis, or NASH. 

HTD1801 is a new molecular entity being developed for NASH as well as primary sclerosing cholangitis (PSC) by HighTide Therapeutics. The Company has completed a first in human study in healthy volunteers; a Phase 2 trial in adults with NASH is due to begin soon in the US. A multicenter Phase 2 trial in adults with PSC is currently ongoing.

“HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia,” said Liping Liu, PhD, CEO of HighTide. 

The Agency has already granted Orphan Drug and Fast Track designation for the PSC indication. 

For more information visit HighTideBio.com.