Exalenz partners on PhIIb study evaluating BreathID in diagnosing NASH

Courtesy of Exalenz

Exalenz Biosciences announced a collaboration with Conatus Pharmaceuticals. The deal will find Conatus using the BreathID Methacetin Breath Test (MBT) to monitor patients in a Phase IIb clinical trial evaluating emricasan.

Emricasan is a treatment for patients experiencing chronic liver disease. Conatus is developing the treatment.

ENCORE-PH, a multicenter, randomized, double-blind and placebo-controlled clinical trial, is expected to begin in 2016 to evaluate the safety and efficacy of the treatment in those suffering with liver cirrhosis associated with nonalcoholic steatohepatitis (NASH) and severe portal hypertension.

BreathID will be used in two breath-based tests. The first will be during the screening stage, while the second will take place at week 24. The announcement noted that the results will look into the clinical utility of BreathID MBT in terms of quantitating improvements in liver function compared with standard medical tests. These include a measurement of hepatic venous pressure gradient (HVPG) and Model for End-stage Liver Disease (MELD) score. Exalenz earned an investigational device exemption from the FDA for the trial.

"To date, emricasan has been studied in more than 650 subjects in 16 clinical trials across a broad range of liver diseases," said Dr. David Hagerty, Conatus' EVP of clinical development, in the announcement. "In multiple clinical trials, emricasan has demonstrated statistically significant improvements in clinically important validated surrogate endpoints of portal hypertension and liver function. 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 data from the BreathID® will provide valuable information to Conatus in the development of novel medicines to treat liver disease, and in bringing new non-invasive diagnostic options to patients."

Raffi Werner, CEO of Exalenz, noted that as it stands, the only way to measure for diagnosis for NASH is an 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,” he said in the announcement.

This is far from Exalenz’s first dip in the diagnostics pool. In August of last year, the company announced a partnership with Galectin Therapeutics on a Phase II clinical trial to study the possibility of using BreathID to diagnose NASH cirrhosis.

- here's the press release