iScience review paper details use of amino
acids in medicine
Axcella focused on designing novel EMM
compositions with the potential to tackle complex diseases; plans
to advance lead candidates into later-stage clinical trials
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company
pioneering a new approach to treat complex diseases and improve
health using endogenous metabolic modulator (EMM) compositions,
today announced a new publication detailing the potential for the
development of EMM compositions that simultaneously target multiple
biological pathways and address unmet needs in a range of complex
diseases. The publication in iScience is now available online.
Amino acids and related metabolites and precursors are a class
of EMMs that have diverse biological functions. Entitled
“Endogenous Metabolic Modulators: Emerging Therapeutic Potential of
Amino Acids,” the new publication reviews literature on the use of
this EMM class to treat diseases, with a focus on single and
combination agents targeted to a single biology.
“This manuscript sheds light on a wealth of clinical precedents
demonstrating the ability to utilize single and simple combinations
of EMMs to reprogram biological pathways,” said Michael Hamill,
Head of Research at Axcella and the publication’s lead author. “It
also describes how, utilizing a rational design approach,
compositions of EMMs provide the potential for compounding
multifactorial effects on a range of complex diseases.”
Complex diseases, which tend to involve the dysregulation of a
variety of underlying pathways and biologies, also are discussed in
the publication. These diseases would be best addressed by safe
multifactorial treatments rather than combination therapies that
can raise the risk of drug-drug interactions and adverse
effects.
Axcella’s EMM compositions are designed to enable a
comprehensive approach, with the potential to simultaneously and
safely target multiple pathways underlying diseases and regulate
biological processes to foster overall health.
“Individual EMMs have been utilized for decades to drive
therapeutic activity with a well-established safety track record,”
said Bill Hinshaw, President and Chief Executive Officer of
Axcella. “At Axcella, we are seeking to harness the full power of
EMMs by developing multi-targeted agents with the potential to
tackle complex diseases like non-alcoholic steatohepatitis (NASH)
and serious complications such as overt hepatic encephalopathy
(OHE). Each of our five clinical studies to date investigating
multiple product candidates have generated positive results,
validating our approach and providing us with confidence in our
ability to address unmet needs for patients with a range of
diseases. We look forward to furthering our leadership in EMMs as
we advance our product candidates into later-stage clinical
trials.”
About Endogenous Metabolic Modulators (EMMs)
EMMs are a broad family of molecules, including amino acids,
that regulate human metabolism. Axcella is developing a range of
novel product candidates that are comprised of multiple EMMs
engineered in distinct combinations and ratios to simultaneously
impact multiple metabolic pathways to modify the root causes of
various complex diseases and improve health.
About Axcella’s Clinical Approach
Each of the company’s clinical studies to date are or have been
conducted as non-investigational new drug application (IND)
clinical studies under U.S. Food and Drug Administration
regulations and guidance supporting research with food. These
studies evaluate product candidates for safety, tolerability and
effects on the normal structures and functions in humans, including
in individuals with disease. They are not designed or intended to
evaluate a product candidate’s ability to diagnose, cure, mitigate,
treat or prevent a disease. If Axcella decides to further develop a
product candidate as a potential therapeutic, as is the case with
AXA1665 and AXA1125, any subsequent clinical studies will be
conducted under an IND.
Internet Posting of Information
Axcella uses its website, www.axcellahealth.com, as a means of
disclosing material nonpublic information and for complying with
its disclosure obligations under Regulation FD. Such disclosures
will be included on the company’s website in the “Investors &
News” section. Accordingly, investors should monitor this portion
of the company’s website, in addition to its press releases, SEC
filings and public conference calls and webcasts.
About Axcella
Axcella is a clinical-stage biotechnology company pioneering a
new approach to treat complex diseases and improve health using
endogenous metabolic modulator (EMM) compositions. The company’s
product candidates are comprised of EMMs and their derivatives that
are engineered in distinct combinations and ratios to
simultaneously impact multiple biological pathways. Axcella’s
pipeline includes lead therapeutic candidates for non-alcoholic
steatohepatitis (NASH) and the reduction in risk of overt hepatic
encephalopathy (OHE) recurrence. Additional muscle- and
blood-related programs are in earlier-stage development. For more
information, please visit www.axcellahealth.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the characteristics and development potential of the
company’s EMM product candidates, as well as compositions of EMMs
in general, the company’s characterization of the results from its
clinical studies and future clinical trials, and the potential of
the company’s product candidates to impact health and/or treat
disease, including NASH and OHE. The words “may,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, those related to the
potential impact of COVID-19 on the company’s ability to conduct
and complete its ongoing or planned clinical studies and
IND-enabled clinical trials in a timely manner or at all due to
patient or principal investigator recruitment or availability
challenges, clinical trial site shutdowns or other interruptions
and potential limitations on the quality, completeness and
interpretability of data the company is able to collect in its
clinical studies or IND-enabled clinical trials, other potential
impacts of COVID-19 on business and financial results, including
with respect to the ability to raise additional capital, make
planned interactions and submissions to FDA or other regulatory
authorities in a timely manner or at all and operational
disruptions or delays, changes in law, regulations, or
interpretations and enforcement of regulatory guidance, whether
data readouts and/or FDA feedback support the company’s IND
submissions and clinical trial initiation plans and timing, whether
and when, if at all, the company’s product candidates will receive
approval from the FDA or other comparable regulatory authorities,
and for which, if any, indications, past results from clinical
studies not being representative of future results, and other risks
identified in the company’s SEC filings, including Axcella’s Annual
Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent
filings with the SEC. The company cautions you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. Axcella disclaims any obligation to
publicly update or revise any such statements to reflect any change
in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent the company’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date. The company explicitly
disclaims any obligation to update any forward-looking
statements.
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Jason Fredette jfredette@axcellahealth.com 857.320.2236
Axcella Health (NASDAQ:AXLA)
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