|BreathID--Courtesy of Exalenz|
The clinical evaluation of cirrhosis can rely upon a whole range of standard medical tests including hepatic venous pressure gradient (HVPG), liver biopsy results, and liver stiffness testing. But Israeli med tech Exalenz Bioscience is working to develop a breath test for its BreathID system that could offer accurate diagnosis and monitoring for a version of the disease, NASH cirrhosis in a Phase II clinical trial with biotech micro-cap Galectin Therapeutics ($GALT).
The hope is that the Exalenz system, dubbed BreathID, can be used to enable physicians to accurately monitor patients in the trial from the point-of-care. During the trial, participants will take three breath-based test. One during the patient-screening test, again after 25 weeks of treatment with Galectin's GR-MD-02 treatment, and finally after the last dose. These results will be compared to those from the standard medical tests; the FDA has already signed off on the study design.
The results of the study will be used to help determine efficacy of BreathID and enable the company to further refine its algorithm for monitoring NASH cirrhosis. The company is also testing the system in liver cancer and clinically significant portal hypertension; the BreathID system is already approved in the U.S., Europe and Israel for detection of the H. pylori bacteria, which is associated with a range of disorders including gastric cancer.
NASH (nonalcoholic steatohepatitis) cirrhosis is caused by a fatty liver that's not from drinking alcohol, but most commonly associated with obesity. Patients often feel well, but have a damaged liver. NASH has been estimated to affect up to 10% of the U.S. population and there are no approved biopharma treatments for it.
As for diagnostics around NASH cirrhosis, "currently the only valid measures for diagnosis and follow up are invasive liver biopsy and HVPG," said Exalenz CEO Raffi Werner in a statement. He continued, we "believe that our non-invasive, operator-independent, breath-based test has the potential to assist clinicians in determining patient suitability for treatment and to conveniently and cost-effectively monitor the effect of therapy at the point of care."
"Early clinical data evaluating GR-MD-02 have been encouraging, demonstrating that our potential treatment for NASH Cirrhosis is safe, well-tolerated and achieved the targeted therapeutic dose," added Galectin CEO, President and CMO Dr. Peter Traber.
"We are excited to be initiating a larger study in a broader patient population, and proud to be partnering with Exalenz Bioscience to further validate how their novel, non-invasive, breath-based technology can be used to select patients with NASH Cirrhosis who are candidates for therapy and to follow up the effect of our drug," he said. "The data from the BreathID will provide valuable information for clinical stage pharmaceutical companies actively working on bringing new therapeutic options to patients."
- here is the release