Categorynews

Terns Pharmaceuticals Initiates a Phase 1 Clinical Trial of TERN-101

June 13, 2019 Off By BusinessWire

Phase 1 study will evaluate the safety and tolerability of TERN-101,
an FXR agonist in development for the treatment of NASH

FOSTER CITY, Calif. & SHANGHAI–(BUSINESS WIRE)–Terns Pharmaceuticals, Inc. today announced the initiation of a Phase 1
clinical trial of TERN-101, an farnesoid X receptor (FXR) agonist, being
developed for the treatment of non-alcoholic steatohepatitis (NASH).
Initiation of the study in the US follows US Food and Drug
Administration (FDA) clearance of the Investigational New Drug
application for TERN-101 filed earlier this year.

“We’ve made significant progress this year, advancing the development of
our lead program, TERN-101, as part of our dedicated approach to NASH, a
condition with no existing treatment options,” said Erin Quirk, M.D.,
Chief Medical Officer of Terns. “We look forward to evaluating data from
this trial later this year as we assess the potential benefits of
TERN-101 in the treatment of NASH.”

The Phase 1 trial of TERN-101 is a randomized, double-blind,
placebo-controlled study designed to evaluate safety, pharmacokinetics,
and plasma biomarkers of FXR pathway activation in participants
receiving placebo or TERN-101 at various dose levels for 7 days.

Initially discovered and developed by Eli Lilly and Company, TERN-101
was previously advanced through a Phase 1 study and demonstrated
clinical pharmacokinetic properties consistent with once daily dosing.
In 2018, Terns announced a global, exclusive
agreement with Eli Lilly to develop, manufacture, and commercialize
TERN-101 for the treatment of NASH. Terns previously presented preclinical
data at The International Liver Congress™ 2019 in Vienna
demonstrating that TERN-101 reduces liver steatosis, inflammation,
ballooning, and fibrosis in a diet-induced obese mouse model of NASH. In
addition to the Phase 1 trial now ongoing in the US, Terns also plans
studies in China as part of the TERN-101 development plan.

About TERN-101 and Farnesoid X Receptor (FXR) Agonism

TERN-101 is a potent non-bile acid FXR agonist being developed as a
therapeutic for NASH. FXR is a nuclear receptor that is highly expressed
in the liver and small intestine. Bile acids (BA) are natural ligands of
FXR, and their binding with and activation of FXR is critical to the
regulation of cellular pathways that modulate BA synthesis, lipid
metabolism, inflammation, and fibrosis. FXR agonism and activation has
demonstrated improvement over placebo in regression of histological
liver fibrosis without progression to NASH in a late-stage study,
demonstrating the potential for FXR agonists to be a new treatment
modality for NAFLD and NASH.

About NASH

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic
fatty liver disease (NAFLD), which is caused by the accumulation of
excess fat in the liver. NASH is associated with chronic liver
inflammation and liver cell injury, and it can lead to fibrosis,
cirrhosis, and eventually liver cancer or liver failure. Global rates of
NAFLD and NASH are increasing rapidly, in tandem with rising rates of
obesity. There is currently no approved medication for the treatment of
NASH.

About Terns Pharmaceuticals

Terns Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company
that is focused on the discovery and development of medicines for
chronic liver disease and cancer. Based in China and the United States,
the company is advancing a pipeline of drug candidates for the treatment
of non-alcoholic steatohepatitis (NASH) and cancer, across multiple
modalities. Terns leverages world class expertise in disease biology,
medicinal chemistry, and clinical development in order to bring
promising new therapies to patients in China and other global markets.

For more information, visit www.ternspharma.com
and www.ternspharma.com.cn