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

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

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

DENVER (April 4, 2019) — 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.

REGULATORY CONTACT:

Sean Bundy | Director of Regulatory and Quality Affairs | sean.bundy@hepquant.com

BUSINESS CONTACT:

Bradley C. Everson | Chief Business Development Officer | brad.everson@hepquant.com