Studies will use BreathID 13C-methacetin breath test to evaluate patient response to therapy
MODI’IN, Israel and MANASQUAN, N.J., July 10, 2018 (GLOBE NEWSWIRE) — Exalenz Bioscience Ltd. (TASE:EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that its BreathID® 13C-methacetin breath test (MBT) will be evaluated in two Phase 2b clinical studies sponsored by Bristol-Myers Squibb. The studies are designed to assess the safety and efficacy of its investigational therapy BMS-986036 (PEG-FGF21) in patients with nonalcoholic steatohepatitis (NASH) and either compensated liver cirrhosis (NCT03486912), or Stage 3 liver fibrosis (NCT03486899). The BreathID platform is already commercially used as a standard of care test for Helicobacter pylori (H. pylori) infection and is currently being tested in two other NASH trials to assess therapeutic response.
The BMS-986036 studies are being conducted in the United States and Japan. Participants at select US sites will have the option to participate in a sub-study using MBT to evaluate treatment response of patients receiving BMS-986036 or placebo, an exploratory endpoint in the trial.
“We are pleased to partner with Bristol-Myers Squibb to assess the ability of the MBT to evaluate patient response to NASH therapy in a placebo-controlled setting,” Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “NASH is a major cause of cirrhosis accompanied by varying stages of fibrosis and affects millions of people globally. A key challenge in diagnosing and managing NASH patients is the need for periodic invasive liver biopsy procedures to monitor disease progression. MBT could be an important noninvasive tool to monitor liver health and assess response to therapy in this large and growing patient population.”
MBT is a simple, noninvasive Point of Care breath-based test in which a patient drinks a half glass of a tasteless solution that is metabolized exclusively in the liver. The patient’s exhaled breath is automatically collected and assayed with the BreathID system to measure the amount of a specific breakdown product of the solution, which reflects the rate of liver metabolism.
In addition to evaluating MBT to monitor NASH patients, it is also being developed to detect CSPH in the advanced NASH patient population, as well as in monitoring patients with confirmed diagnoses of acute liver failure (ALF). The ability to monitor patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases.
More than 8 million people in the United States and Europe are living with advanced non-alcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD) and a major risk factor for liver transplant and the development of primary liver cancer. The incidence of NAFLD is expected to increase more than 21% by 2030, with a concomitant increase of more than 63% in the incidence of NASH in the same period.
About Exalenz Bioscience
Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH. Additional information is available at www.exalenz.com.