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Axcella Presents Late-Breaker Data Demonstrating Lead AXA™ Candidate AXA1665 Impacted Markers Related to Liver Health

April 11, 2019 Off By BusinessWire

Increased Fischer’s ratio in subjects with mild-moderate hepatic
insufficiency
Impacted biomarkers of liver-related health
Muscle mass maintained, with an impact on clinically relevant
function

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, presented new data on the
company’s novel endogenous metabolic modulator (EMM) composition,
AXA1665, in subjects with mild and moderate hepatic insufficiency or
loss of liver function, at The International Liver Congress™ 2019
(EASL). These data from a Non-IND, IRB-Approved Clinical Study were
presented in a poster presentation 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.

“Cirrhosis complications are impacted by multiple drivers including the
dysregulation of amino acid and urea cycle metabolism, muscle wasting,
and gut health. There is a clear unmet need for approaches that address
these multiple drivers,” said Dr. Sanyal.

AXA1665, Axcella’s lead candidate, was designed to target multiple
metabolic pathways intersecting key organ systems, including liver,
muscle and gut to maintain liver health. Primary assessments from the
study in subjects with mild and moderate hepatic insufficiency showed
that AXA1665 was well tolerated in the study, and secondary assessments
demonstrated that AXA1665:

Increased the basal (fasted) Fischer’s ratio by 40%;
Decreased plasma ammonia area under the curve; and
Tended to maintain a leaner phenotype and muscle function.

“I am very pleased to see additional positive results from our liver
pipeline. These data suggest that AXA1665 impacts amino acid and ammonia
homeostasis and tends to maintain a leaner phenotype with clinically
relevant functional improvements,” said Manu Chakravarthy, M.D., Ph.D.,
Senior Vice President, Clinical Development and Chief Medical Officer of
Axcella. “These findings support our belief that AXA1665 has the
potential to directly address the multifactorial risk-factors of liver
health and disease.”

“We are delighted to have these important data presented at EASL,” said
Bill Hinshaw, President and Chief Executive Officer of Axcella. “AXA1665
progressed from biological hypothesis to readout of initial Non-IND,
IRB-Approved Clinical Study data in less than 18 months. We are highly
encouraged by these results and are actively advancing our AXA1665
clinical program. Data from our predictive, rapid and scalable
human-focused AXA Development Platform continue to support EMMs as novel
multifactorial assets with the potential to support health or become
therapeutically relevant.”

About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar,
attracting scientific and medical experts from around the world to learn
about the latest in liver research. Attending specialists present,
share, debate and conclude on the latest science and research in
hepatology, working to enhance the treatment and management of liver
disease in clinical practice. This year, the congress is expected to
attract approximately 10,000 delegates from all corners of the globe.
The International Liver Congress™ 2019 will take place from 10–14 April
2019 at the Reed Messe Wien Congress and Exhibition Center, Vienna,
Austria.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organization has grown
to over 4,000 members from all over the world, including many of the
leading hepatologists in Europe and beyond. EASL is the leading liver
association in Europe, having evolved into a major European association
with international influence, and with an impressive track record in
promoting research in liver disease, supporting wider education and
promoting changes in European liver policy.

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.