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.