Axcella released an update from the ongoing clinical study of two potential therapies for nonalcoholic fatty liver disease that showed the compounds were safe, well-tolerated, and demonstrated relevant clinical response, according to a press release.
“These interim noninvasive data indicate that AXA1125 and AXA1957 are having a positive impact on multiple dysregulated biological pathways related to health and disease that are common in NAFLD [and nonalcoholic steatohepatitis] patients,” Stephen A. Harrison, MD, from Pinnacle Clinical Research in San Antonio, Texas, and principal investigator of the study said in the release. “These are particularly encouraging early findings, providing hope that a multifactorial effect can be generated from novel compositions of endogenous metabolic modulators.”
Study investigators completed enrollment of 102 adults with NAFLD and randomly assigned patients to receive either AXA1125, one of two AXA1957 doses, or placebo for 16 weeks.
Interim analysis at the halfway point showed a positive safety and tolerability profile along with responses on three biological nodes: metabolism based on magnetic resonance imaging proton density fat fraction and homeostatic model assessment of insulin resistance; inflammation based on alanine aminotransferase, cytokeratin-18, and corrected T1; and fibrogenesis based on PRO-C3.
“We are pleased with the swift pace of enrollment and the data generated to date in our sizable clinical study of AXA1125 and AXA1957,” Bill Hinshaw, president and CEO of Axcella, said. “The interim analysis increases our confidence in the potential for these candidates to become foundational therapeutics for NASH patients. Our excitement continues to build as we begin a major year for the company, with five planned clinical readouts and the initiation of our first planned phase 2b/3 clinical trial in 2020.”
Editor's note: The article has been updated to correct 'cardiotrophin-1' with 'corrected T1.'