Axcella to Present Late-Breaker Data on Lead AXA™ Candidate, AXA1665 at EASL, the International Liver Congress™

March 27, 2019 Off By BusinessWire

CAMBRIDGE, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/AXAcandidates?src=hash” target=”_blank”gt;#AXAcandidateslt;/agt;–Axcella Health, a biotechnology company pioneering the research and
development of novel multifactorial interventions to address
dysregulated metabolism and support health, today announced a
late-breaker poster presentation for their novel endogenous metabolic
modulator (EMM) composition, AXA1665 in subjects with mild and moderate
hepatic insufficiency. These data from a Non-IND, IRB-Approved Clinical
Study will be presented at the European Association for the Study of the
Liver (EASL), The International Liver Congress™ 2019 taking place April
10-14 in Vienna, Austria, by Arun J. Sanyal, M.B.B.S., M.D., Professor,
Department of Internal Medicine, Division of Gastroenterology,
Hepatology and Nutrition, Virginia Commonwealth University School of
Medicine.

Additional details of the presentation are as follows:

Title: AXA1665, a novel composition of amino acids restores the
dysregulated amino acid profile, lowers ammonia, and improves body
composition and function in Child-Pugh class A and B subjects

Abstract Number: 5217

Identifier: LBP-31

Presenter: Arun J. Sanyal, M.B.B.S., M.D., Professor, Department
of Internal Medicine, Division of Gastroenterology, Hepatology and
Nutrition, Virginia Commonwealth University School of Medicine

Session: Late breaker poster

Date/Time: Thursday, April 11, 2019 at 9am CET until Saturday,
April 13, 2019 at 5pm CET

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.