The Food and Drug Administration (FDA) has granted Fast Track designation to TERN-201 (Tern Pharmaceuticals) for the treatment of nonalcoholic steatohepatitis (NASH).
TERN-201, a highly-selective semicarbazide-sensitive amino oxidase (SSAO) inhibitor, is believed to work by reducing oxidative stress and recruitment of white blood cells to the liver, thereby potentially reducing inflammation and hepatic fibrosis. “Prior study of SSAO inhibition in NASH patients has demonstrated significant improvement in markers of liver injury and cell death,” said Erin Quirk, MD, President and Chief Medical Officer of Terns.
In a phase 1 clinical study, single and multiple oral administrations of TERN-201 were found to be well tolerated with no significant safety findings observed. Moreover, each dose level was associated with near complete inhibition of plasma SSAO activity, which was maintained up to 1 week with repeat administration.
“Terns has confidence that TERN-201 has the potential to be a best-in-class SSAO inhibitor, which could greatly benefit people living with NASH and other inflammatory diseases, and we look forward to advancing it to studies in NASH patients early next year,” added Quirk.
The Company is also investigating TERN-101, a liver-selective farnesoid X agonist, in an ongoing phase 2a clinical trial for the treatment of NASH.
For more information visit ternspharma.com.
Terns Pharmaceuticals receives fast track designation for TERN-201 as a treatment for NASH. https://www.businesswire.com/news/home/20200910005090/en/Terns-Pharmaceuticals-Receives-Fast-Track-Designation-TERN-201. Accessed September 10, 2020.