Axcella Announces Patent Issuance for AXA Candidate AXA1125

“The issuance of this patent by the U.S. Patent and Trademark Office affirms the patentability of the unique compositions of one of Axcella’s AXA Candidates as well as, we believe, our company’s inventiveness. We note that to date Axcella solely owns all of its patent rights,” said Paul F. Fehlner, J.D., Ph.D., Senior Vice President, Chief Intellectual Property Officer of Axcella.

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 (IND), Institutional Review Board (IRB)-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.

“As a first mover in our approach to EMMs, we are proactively building a broad, multi-dimensional intellectual property portfolio that includes human data as a strategic asset that has the potential to provide us with a significant competitive advantage,” said Bill Hinshaw, President and Chief Executive of Axcella. “This issuance represents another important milestone demonstrating the power of our development paradigm and innovative platform.”

About Endogenous Metabolic Modulators
Endogenous metabolic modulators are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA Candidates are comprised of EMMs that individually have a history of safe use as food. We believe 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.

About Non-IND, IRB-Approved Clinical Studies
Axcella conducts Institutional Review Board (IRB)-approved, non-investigational new drug application (Non-IND) clinical studies in humans with its AXA candidates under U.S. 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.

About Axcella Health
Axcella is designing and developing AXA candidates, compositions of EMMs matched to biologies and engineered in distinct ratios, with the aim of maximizing the vital role that EMMs play in regulating multiple metabolic functions. Our 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. We believe our leading expertise and capabilities in EMMs position us to become a preeminent company reprogramming metabolism to address a diverse set of complex diseases and support health. Our AXA Development Platform has already produced a pipeline of product candidates in programs targeting liver, muscle and CNS. We were founded by Flagship Pioneering.

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