Exalenz Bioscience has partnered with Conatus Pharmaceuticals to provide its BreathID Methacetin breath test (MBT) for monitoring patients in a planned Phase IIb clinical trial, which is assessing emricasan.
Emricasan is an investigational treatment, which is currently under development by Conatus, to treat patients with chronic liver disease.
The Encore-PH multicenter, randomized, double-blind and placebo-controlled clinical trial has been designed to assess the safety and efficacy of emricasan in patients with liver cirrhosis associated with nonalcoholic steatohepatitis (NASH) and severe portal hypertension.
The patients recruited in the study will secure two breath-based tests, including one during the screening stage and the second at week 24.
The results will be used to assess the clinical utility of the BreathID MBT at quantitating improvements in liver function compared to standard medical tests such as hepatic venous pressure gradient (HVPG) and model for end-stage liver disease (MELD) score.
Recently, Exalenz secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the trial.
Conatus clinical development executive vice president Dr David Hagerty said: “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.”
Exalenz Bioscience CEO Raffi Werner said: “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."
Exalenz Bioscience is engaged in the development of diagnostic and monitoring systems to diagnose and manage gastrointestinal and liver conditions.