Data from Axcella’s AXA1125 Program Supports New Approach Leveraging Endogenous Metabolic Modulators to Reprogram Cellular Physiology

• AXA1125 was safe and well tolerated with impact on liver function biomarkers of metabolism, inflammation, and fibrosis
• Consistency and fidelity of signals across human, rodent and cellular systems

CAMBRIDGE, Mass., November 12, 2018 – Axcella Health, a biotechnology company pioneering a new approach to address metabolic health and dysregulation, released topline data on the company’s novel candidate, AXA1125, at The 2018 Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Axcella’s new data were showcased in an oral presentation given by Manu Chakravarthy, M.D., Ph.D., Senior Vice President, Clinical Development and Chief Medical Officer of Axcella.

“The complexity of maintaining liver health likely requires a combinatorial approach. Progressive loss of liver health can result in liver dysfunction such as Non-Alcoholic Fatty Liver Disease (NAFLD). NAFLD is emerging as an epidemic given its close association with obesity and type 2 diabetes in both adult and pediatric populations,” commented Stephen Harrison, M.D., Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford.

“AXA1125, a novel composition comprising Endogenous Metabolic Modulators, was safe and well tolerated in type 2 diabetes subjects with NAFLD over a 12-week period in a pilot IRB-approved, Non-IND study. We also observed the impact of AXA1125 on hepatic function biomarkers of metabolism, inflammation, and fibrosis, with consistency and fidelity of signals across human, rodent and cellular systems. We are highly encouraged by these promising data, which further our understanding of endogenous modulators and their impact on liver metabolic pathways,” said Dr. Chakravarthy.

“These data support our innovative approach as we continue to advance our liver program, and further validate our platform’s potential to generate candidates that either support health or address a broad set of complex diseases all linked by metabolic modulation,” said Bill Hinshaw, President and Chief Executive Officer of Axcella.

In addition to presenting data on AXA1125, Axcella also recently presented data on another candidate, AXA2678, at the 2018 American College of Sports Medicine Conference on Integrative Physiology of Exercise. These data showed AXA2678 to be safe and well tolerated in an IRB-approved, Non-IND study in healthy subjects, with an impact on normal muscle structure and function in a limb immobilization model.

About Endogenous Metabolic Modulators

Endogenous metabolic modulators (EMMs), which include amino acids, regulate fundamental health and disease pathways. Compositions leveraging EMMs hold significant promise, with several advantages over traditional drugs and food/dietary supplement products, including their ability to simultaneously impact multiple biological pathways and history of safe use.

About Non-IND Clinical Studies

Axcella conducts pre-IND, IRB-approved food studies to evaluate the safety and tolerability of its AXA candidates in human subjects, or effects on the normal structure or function of the body. Studies intended to directly support drug development will be conducted under an IND. Axcella has not determined the development path for AXA1125 or AXA2678.

About Axcella™ Health

Axcella is designing and developing novel endogenous metabolic modulator compositions to safely reprogram metabolic dysregulation. We are transforming the discovery and development of traditional drug and consumer health candidates from concept to clinical stages, by leveraging our deep understanding of human biology. Our novel approach rapidly gains unprecedented information in a capital efficient manner. Our platform has already produced a rich pipeline of product candidates in programs targeting liver, muscle, and CNS. Axcella Health was founded by Flagship Pioneering. www.axcellahealth.com