Axcella Announces Patent Issuance for AXA™ Candidate AXA1125 Methods of Use

April 2, 2019 Off By BusinessWire

- Patent issuance from Axcella’s broad Endogenous Metabolic Modulator
  (EMM) portfolio

- Claims cover methods of use of EMM compositions in liver dysfunction
  and liver disease

- Issuance expands protection of Axcella’s pipeline of AXA Candidates

CAMBRIDGE, Mass.–(BUSINESS WIRE)—-Axcella
Health, a biotechnology company pioneering the research and
development of novel multifactorial interventions to address
dysregulated metabolism and support health, today announced the issuance
of U.S. Patent 10,238,617 with claims covering methods of use for AXA
Candidate AXA1125, the Company’s EMM composition, to address liver
dysfunction and liver disease, including fatty liver disease. The patent
was issued on March 26, 2019.

“This issuance covers use of a broader class of EMM compositions and
expands Axcella’s protection of our AXA Candidates, and proprietary
human-focused AXA Development Platform,” said Paul F. Fehlner, J.D.,
Ph.D., Senior Vice President, Chief Intellectual Property Officer of
Axcella. “These patents and our entire portfolio are fully owned by
Axcella.”

AXA1125 is a novel composition of EMMs designed to simultaneously
support metabolic, inflammatory and fibrotic pathways associated with
liver health. Axcella was previously granted a patent related to AXA1125
with claims covering compositions of matter independent of any
particular use.

“This additional issuance continues to strengthen our global
intellectual property position with patent rights that include coverage
for our AXA Candidates, manufacturing and formulations,” said Bill
Hinshaw, President and Chief Executive Officer of Axcella.

About Endogenous Metabolic Modulators
Endogenous metabolic
modulators, or EMMs, are a broad family of molecules, including amino
acids, which fundamentally impact and regulate human metabolism. Our AXA
Candidates are anchored by EMMs that 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 support and modulate multiple
metabolic pathways implicated both in complex diseases and overall
health.

About Non-IND, IRB-Approved Clinical Studies
Axcella
conducts non-investigational new drug application (Non-IND),
Institutional Review Board (IRB)-approved clinical studies in humans
with its AXA Candidates under U.S. Food and Drug Administration
regulations and guidance supporting research with food outside of an
IND. 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 engineered in distinct ratios, designed
to target and maximize the fundamental role that EMMs play in regulating
multiple metabolic functions. Our AXA Candidates are generated from our
proprietary, human-focused AXA Development Platform. We believe our
expertise and capabilities in EMMs position us to become a preeminent
biotechnology 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 central nervous system. We were founded by Flagship
Pioneering.