HepQuant’s Disease Severity Index (DSI) Demonstrates Hepatic Functional Improvement in High Percentage of NASH Patients Treated with Obeticholic Acid: Results from INTERCEPT 747-117

April 4, 2019 Off By BusinessWire

The First HepQuant SHUNT™ Data From An Interventional Drug Study
in NASH

DENVER–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/NASH?src=hash” target=”_blank”gt;#NASHlt;/agt;–HepQuant,
LLC, a Greenwood Village, Colo.-based company with a unique,
patented and patent-pending blood-based technology for evaluating the
function of the liver, today announced the results from its proprietary
HepQuant SHUNT™ Liver Diagnostic Kit in INTERCEPT’s placebo-controlled
clinical trial of obeticholic acid (OCA), 747-117.

The HepQuant DSI results from the trial will be presented as a Late
Breaker poster (LBP-18) at International Liver Congress™ 2019, the 54th
Annual Meeting of the European Association for the Study of the Liver
(EASL) in Vienna, Austria April 10 – 14, 2019.

HepQuant measures the hepatic extraction of exogenously administered
labeled cholate as a marker of liver function, which has been correlated
to clinical outcomes using a Disease Severity Index (DSI), a liver score
from 0 to 50. Based on prior studies of the relationship of DSI to
probability of varices, a 2-point decrease in DSI is proposed as
clinically meaningful.

The study evaluated 84 days of treatment with placebo, 10 mg/d OCA, or
25 mg/d OCA in subjects with fibrotic stages of Non-Alcoholic
SteatoHepatitis (NASH). HepQuant’s DSI demonstrated a dose-dependent
improvement based on greater than a 2-point decline in DSI. In
comparison to the fibrosis reduction observed after 18 months of OCA in
the phase 3 REGENERATE trial, the results from this study (747-117)
suggest that liver functional improvement may occur early and in a
higher percentage of OCA-treated persons.

In announcing these results, Dr. Gregory T. Everson, CEO & Chief Medical
Officer at HepQuant, LLC, stated, “The results of this short-term,
placebo-controlled trial are exciting because they indicate that
HepQuant DSI could be an important monitoring tool for drug development.”

In the 747-117 study the response rates for NASH patients with F2 and F3
fibrosis were 0% (0/5), 36% (4/11), and 73% (8/11) based on a 2-point
reduction in DSI after 84 days of treatment. To put these results in
context, the REGENERATE 18 month phase 3 study demonstrated response
rates of 11.9% (n=311) for placebo, 17.6% (n=312) for OCA 10 mg/d, and
23.1% (n=308) for OCA 25 mg/d in F2/F3 subjects based on a ≥ 1 stage
reduction in fibrosis without worsening NASH at the 18 month liver
biopsy.

This is the first completed study of the use of the HepQuant SHUNT Liver
Diagnostic Kit and DSI in a NASH clinical trial. The abstract
is titled “Effect of Obeticholic Acid on Liver Function in Patients with
Fibrosis due to NASH.”

In prior research studies, DSI has been associated with likelihood for
varices and risk for future clinical outcomes (ascites, encephalopathy,
variceal hemorrhage, liver-related death), particularly in chronic
hepatitis C.

About HepQuant SHUNT™

The HepQuant SHUNT™ Liver Diagnostic Kit is used for assessment of liver
function through the quantitative detection of ¹³C-cholate
and d4-cholate in blood serum, collected after the intravenous
administration of ¹³C-cholate and the oral ingestion of
d4-cholate. The HepQuant SHUNT Liver Diagnostic Kit is being studied as
an aid in the determination of the likelihood of large esophageal
varices in patients with Chronic Liver Disease (CLD). The SHUNT-V
pivotal study is currently enrolling 420 subjects at up to 20 U.S.
research sites.

About HepQuant

Headquartered in Greenwood Village, Colorado, HepQuant, LLC, is a
privately-held, early-stage combination drug and in-vitro diagnostic
company. HepQuant’s products are investigational combination drug and
in-vitro diagnostic devices and have not yet been evaluated or reviewed
by the US Food and Drug Administration (FDA) for commercial sale. They
are currently available for investigational use via the FDA IDE
application process. For additional information, visit www.hepquant.com.