13 February 2019 - - US Patent 10,201,513 has been issued with claims covering compositions of matter including US-based biotechnology company Axcella Health's AXATM Candidate AXA1125, independent of any particular use, the company said.

Axcella is pursuing patent protection for its unique products, innovative approaches to treating disease and maintaining good health, and the underlying enabling technologies associated with the development of these products.

AXA1125 is a novel composition of EMMs designed to simultaneously support metabolic, inflammatory and fibrotic pathways associated with liver health.

Non-Investigational New Drug, Institutional Review Board -approved clinical, and mechanistic data from Axcella's liver program on AXA1125 were recently presented at the AASLD Liver Meeting and the Integrated Pathways of Disease in NASH and NAFLD Keystone Symposium.

These data provide evidence that compositions of EMMs are novel multifactorial assets with the potential to support health or become therapeutically relevant.

Endogenous metabolic modulators are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism.

Its AXA Candidates are comprised of EMMs that individually have a history of safe use as food.

The company believes that, unlike conventional targeted interventions currently used to address dysregulated metabolism, EMM compositions have the potential to directly and simultaneously modulate multiple metabolic pathways implicated both in complex diseases and overall health.

Axcella conducts Institutional Review Board -approved, non-investigational new drug application (Non-IND) clinical studies in humans with its AXA candidates under US Food and Drug Administration regulations and guidance supporting research with food.

In these studies, Axcella evaluates in humans, including in individuals with disease, AXA Candidates for safety, tolerability and effects on the normal structures and functions of the body.

Non-IND, IRB-Approved Clinical Studies are not designed or intended to evaluate an AXA Candidate's ability to diagnose, cure, mitigate, treat or prevent a disease.

If Axcella decides to further develop an AXA Candidate as a potential therapeutic, subsequent studies will be conducted under an IND.

Axcella is designing and developing AXA candidates, compositions of EMMs matched to biologies and engineered in distinct ratios, with the aim of maximising the vital role that EMMs play in regulating multiple metabolic functions.

Its AXA Candidates are generated from our proprietary, human-focused AXA Development Platform and harness the power of EMMs, a broad family of molecules that fundamentally impact and regulate human metabolism.