Investigators have completed trial enrollment for two novel compositions of endogenous metabolic modulators under evaluation as interventions to address dysregulated metabolism in patients with nonalcoholic fatty liver disease, according to a press release from Axcella.
“NAFLD is one of, if not the most common chronic liver diseases we face today. The more aggressive component of NAFLD, non-alcoholic steatohepatitis (NASH), is found in up to 25% of these patients and can progress to cirrhosis, liver decompensation and hepatocellular carcinoma,” Stephen Harrison, MD, principal investigator from Oxford University, United Kingdom, said in the release. “Due to this growing epidemic and lack of currently available therapies, we are keen to find effective interventions, and I am very pleased with the progress of the ongoing Axcella study.”
Investigators enrolled approximately 105 patients with NAFLD in the randomized control trial to evaluate safety, tolerability and physiological impact of AXA1125 and AXA1957 after 16 weeks of treatment.
Additionally, Axcella initiated a randomized control trial of AXA1957 in adolescent patients with NAFLD in the third quarter of 2019. The company anticipates the data readout from this study in the second half of 2020.
“Fatty liver in obese children is becoming a huge public health burden given its strong association with type 2 diabetes, future cardiovascular risk and many other complications,” Saul Faust, MD, PhD, principal investigator of the adolescent trial from the Southampton National Institute for Health Research Clinical Research Facility, said. “To date, we have been encouraged by the level of interest of clinical investigators, their adolescent subjects and parents in connection with participating in the ongoing Axcella study.”