Axcella Presents Data for AXA1125 at The Liver Meeting 2020

Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today shared details about the company’s poster presentations at The Liver Meeting 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place virtually today through November 16, 2020. Both presentations feature data from AXA1125-003, a placebo-controlled, randomized clinical study that enrolled 102 subjects with presumed nonalcoholic steatohepatitis (NASH) to assess the impact of AXA1125 and AXA1957 on safety, tolerability and effects on structures and functions of the liver for 16 weeks.

“The results of AXA1125-003 were a key milestone for Axcella in which we were able to demonstrate clinically relevant multifactorial effects with AXA1125 in subjects with presumed NASH,” said Manu Chakravarthy, M.D., Ph.D., Axcella’s Chief Medical Officer and Executive Vice President of Clinical Development. “At The Liver Meeting this week, we are sharing further data from this study. Based on AXA1125’s data to date and its multi-targeted mechanism of action, we believe this candidate is well positioned to be a first-line NASH therapy with potentially differentiating effects in type 2 diabetic subjects. We look forward to investigating its impact on liver histology in our upcoming serial biopsy Phase 2b clinical trial in patients with biopsy-proven NASH.”

Abstract 1663 is entitled “Biological Activity of AXA1125 and AXA1957 on Glucose, Insulin, HOMA-IR, and HbA1c and Measures of Liver Fat and Fibroinflammation in a Prospective 16-Week Randomized, Placebo-Controlled Study in Subjects with NAFLD and Type 2 Diabetes.” This presentation highlights reductions seen in subjects receiving AXA1125 vs. placebo in markers of metabolism (MRI-PDFF and HOMA-IR) and fibroinflammation (cT1, ProC3 and FIB-4) as well as the reduction over time in ALT through 16 weeks. Additionally, the presentation shows the increased proportion of subjects receiving AXA1125 vs. placebo that achieved clinically relevant thresholds of improvement in specific markers, including: