Exalenz Bioscience announces positive clinical trial results for the diagnosis of clinically significant portal hypertension in NASH patients

Exalenz Bioscience Announces Positive Clinical Trial Results For the Diagnosis of Clinically Significant Portal Hypertension in NASH Patients

 Easy-to-administer, noninvasive BreathID® test offers multiple advantages over alternative invasive detection methods Potential 2020 entry to an addressable U.S. market of millions of NASH patients

 Modi’in, Israel and Manasquan, NJ, January 23, 2018 — 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 platform, which is already commercially used as a standard of care test for Helicobacter pylori (H. pylori), showed positive clinical trial results in detecting clinically significant portal hypertension (CSPH) in non-alcoholic steatohepatitis (NASH) patients with compensated advanced chronic liver disease (cACLD). CSPH has been shown to be the most important independent predictor of several liver related complications in this population. Data from a total of 257 NASH patients who participated in two parallel studies comparing the use of the BreathID 13C-methacetin breath test (MBT) to invasive measurement of portal pressure demonstrate that MBT had high sensitivity and specificity in this patient population (88% and 85% respectively).

CSPH, a severe complication of chronic liver disease and cirrhosis characterized by elevated pressure in the vein carrying blood from the gastrointestinal tract to the liver, is closely associated with an increase in severe liver complications, morbidity and mortality. Current methods for detecting CSPH are invasive, complex and highly operator dependent, expose patients to radiation and require injection of contrast materials.

“Diagnosing CSPH in NASH patients is critical for effective intervention that can prevent further loss of liver function, improve patient outcomes and reduce the cost of care,” said Professor Scott Friedman, Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine, Mount Sinai New York. “Current invasive and complex testing methods are not widely accessible and thus, a noninvasive CSPH test is essential for meeting the needs of the large and growing population of NASH patients. Results from these studies suggest that BreathID could be the first effective, noninvasive test that would allow us to improve the management of late-stage NASH patients who are at risk for portal hypertension.”

The study populations comprised 257 NASH patients with a mean age of 59 years, mean body mass index (BMI) of 34.6 and a CSPH prevalence of 62.3%. A preliminary model to detect CSPH using MBT was developed with an Area Under the Receiver Operator Curve (AUROC) of 0.88. Cutoffs were established to achieve 88% sensitivity and 85% specificity, with 10% indeterminate results.

“Exalenz is committed to leveraging our proven BreathID platform to innovate new breath-based tests for a broad range of liver and gastrointestinal disorders,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We are very encouraged by the results of these two clinical trials demonstrating that MBT effectively detects CSPH in NASH patients, which could give clinicians a novel noninvasive tool to improve the management of this growing, complex patient population. We have a strategy in place to bring this innovative test to market with a potential product launch in 2020”.

About MBT 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 detecting CSPH in NASH, MBT is being evaluated in monitoring patients with confirmed diagnoses of acute or chronic liver disease. The ability to monitor these patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases. Exalenz is also collaborating with pharmaceutical companies to assess the utility of MBT in monitoring response to treatment.

About NASH More than 8 million people in the United States and Europe are living with advanced nonalcoholic 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 CSPH Clinically significant portal hypertension (CSPH), a complication of chronic liver disease and cirrhosis in which there is an increase in pressure in the vein that carries blood from the gastrointestinal tract to the liver, is closely associated with an increase in liver related morbidity and mortality. Detecting CSPH in patients with NASH is important for assessing the risk of developing liver complications, initiating therapeutic interventions to reduce portal hypertension and determining the need for additional procedures and/or monitoring. Portal pressure is measured by hepatic venous pressure gradient (HVPG), an invasive, complex and highly operator dependent procedure that exposes the patient to radiation and requires injection of contrast materials

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.

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