There is a growing need for a simple non-Invasive diagnostic system that accurately scores Non-Alcoholic Steatohepatitis (NASH) and monitors disease severity. NASH is a major cause of acute liver dysfunction and dramatically increases the risk of cirrhosis, liver failure and hepatocellular carcinoma (HCC), often necessitating liver transplantation. The only current definitive diagnosis of NASH is invasive liver biopsy.
Exalenz is rising to the challenge with its patented BreathID® technology, offering an advanced noninvasive breath testing solution that delivers impactful insight into functional diagnosis and follow-up of NASH. The BreathID® system is currently used in a series of trials, both company-sponsored and in collaboration with pharmaceutical companies, to establish its reliability and accuracy for diagnosing and monitoring NASH.
Collaboration with Conatus Pharmaceuticals to use BreathID® for Monitoring Patients with Cirrhosis Associated with NASH
Exalenz is collaborating with Conatus Pharmeceuticals to use BreathID® to quantitate improvement in liver function in a Phase IIb clinical trial evaluating emricasan, an investigational treatment for patients with chronic liver disease. The study ENCORE-PH is a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted in the US and Europe.
Collaboration with Galectin Therapeutics to use BreathID® for Monitoring Patients with Cirrhosis Associated with NASH
Exalenz is collaborating with Galectin Therapeutics to use BreathID® to follow treatment of GR-MD-02 in a Phase II clinical study. GR-MD-02 is an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis). The multicenter, randomized, placebo-controlled, double-blind clinical trial will evaluate the safety and efficacy of GR-MD-O2 for the treatment of liver fibrosis and portal hypertension in patients with NASH Cirrhosis.
Exalenz sponsord multinational Study of Breath-Based Tests to Diagnose NASH
Exalenz is conducting a multinational study in the U.S. and Europe, evaluating the potential of BreathID® in diagnosing NASH. The 200-patient multicenter study aims to replace the current modalities of standard pathological examination, blood testing, and liver biopsy, which are invasive and potentially inaccurate due to sampling errors and other interpretational limitations.