Axcella, a renowned clinical-stage biotechnology firm aimed at leveraging EMMs (endogenous metabolic modulators) to pioneer a unique and new approach for the treatment of complex diseases and enhancing health, has reportedly announced positive top-line results from AXA1125-003.
AXA1125-003 is a randomized, placebo-controlled, and multi-arm clinical study evaluating the impact of AXA1957 and AXA1125 on tolerability, safety, and effects over functions and structures of the liver, as assessed by a comprehensive team of imaging and soluble biomarkers connected to inflammation, metabolism, and fibrosis.
Both AXA1957 and AXA1125 are different product candidates and are proprietary compositions of derivatives and amino acids designed to aid liver health. 102 adult NAFLD (non-alcoholic fatty liver disease) subjects were tested in this non-IND trial, the participants with presumed NASH (non-alcoholic steatohepatitis), on the basis of inclusion criteria, were dosed with AXA1125 with a ratio of 2:2:2:1, one of two doses of AXA1957, or a placebo administered twice every day for about 16 weeks. Subjects in the trial were stratified on the basis of the absence or presence of type 2 diabetes.
Outcomes from this trial showed that AXA1957 and AXA1125 were usually well-tolerated, with certain levels of sustained reductions recorded for both the product candidates versus placebo in important biomarkers of inflammation, fibrosis and metabolism for more than 16 weeks.
The Chief Medical Officer at Axcella, Manu Chakravarthy, M.D., Ph.D., stated that in AXA1125-003, the company was seeking to evaluate tolerability and safety while also finding what differential responses might be observed from AXA1957 and AXA1125 across markers of inflammation, fibrosis, and metabolism.
Chakravarthy further added that it is gratifying that a multifactorial activity as well as favorable tolerability profile were recorded for AXA1125 in the placebo-controlled, multi-arm randomized trial, which replicates outcomes from the company’s previous clinical trial in patients with type 2 diabetes and NAFLD.