Trial of emricasan to use BreathID to monitor patients with NASH

Exalenz Bioscience announced a collaboration with Conatus Pharmaceuticals Inc. to use the BreathID Methacetin Breath Test to monitor patients in a phase2b trial evaluating emricasan, according to a press release.

“To date, emricasan has been studied in more than 650 subjects in 16 clinical trials across a broad range of liver diseases,” David T. Hagerty, MD executive vice president of clinical development at Conatus, said in the release. “We are pleased to be partnering with Exalenz Bioscience to further validate how their novel, non-invasive, breath-based technology can be used to monitor patients treated for NASH cirrhosis.”

The BreathID Methacetin Breath Test (MBT) detects the presence of H. pylori bacteria, which are associated with various illnesses, the release said. Currently, over 350 medical centers use the technology to quantify improvements in liver function. Conatus is developing emricasan — an orally active pan-caspase protease inhibitor designed to reduce activity of enzymes that can mediate inflammation and apoptosis in patients with chronic liver disease.

The ENCORE-PH trial will evaluate the safety and efficacy of emricasan in patients with liver cirrhosis associated with nonalcoholic steatohepatitis and severe portal hypertension, according to the release. In addition, patients will receive two breath-based tests, including the BreathID MBT. Researchers will use the results to compare BreathID with standard tests, including the hepatic venous pressure gradient (HVPG) and MELD score.

Recently, the FDA gave approval to Exalenz for an investigational device exemption in the trial, the release said.

“It has been reported that NASH affects 2% to 5% of the U.S. population, in addition to the 10% to 20% of the population with fatty liver without inflammation,” Rafi Werner, CEO of Exalenz Bioscience, said in the release. “Currently, the only valid measures for diagnosis and follow-up are invasive liver biopsy and HVPG. We are honored to collaborate with Conatus in the upcoming multicenter clinical trial and believe that our non-invasive, operator-independent, breath-based test has the potential to assist clinicians to conveniently and cost-effectively monitor the effect of therapy at the point of care.” – by Will Offit

Disclosure: Hagerty is employed by Conatus Pharmaceuticals Inc. Werner is employed by Exalenz Bioscience.