Newly issued U.S. patent covers elements of
Axcella’s muscle program
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company
focused on leveraging endogenous metabolic modulators (EMMs) to
pioneer a new approach for treating complex diseases and improving
health, today announced the issuance of U.S. Patent 10,596,136.
This patent broadly covers the use of the company’s initial muscle
product candidate, AXA2678, and related EMM compositions for the
reduction of fat infiltration in muscle.
“This patent is the first to cover key elements of Axcella’s
muscle program, including an important use of our initial muscle
candidate,” said Paul F. Fehlner, J.D., Ph.D., Senior Vice
President and Chief Intellectual Property Officer of Axcella. “This
issuance is key for Axcella as it broadens our patent portfolio to
cover additional areas and assets outside of the liver space. It
also further solidifies Axcella’s position as we seek to
demonstrate the ability for EMM compositions to address metabolic
dysregulations across a wide range of organ systems.”
Over the course of the past several years, Axcella has worked
aggressively to establish a first-mover advantage in the use of
EMMs to treat complex diseases and conditions. In addition to
Axcella’s four granted U.S. patents, the company has established 18
patent families and more than 125 additional worldwide patents
pending.
“We believe EMM combinations have the unique ability to target
and impact multiple biological pathways simultaneously,” said
Shreeram Aradhye, M.D., Executive Vice President and Chief
Development Officer at Axcella. “This issuance focuses on specific
EMM combinations that are intended to modulate key metabolic
pathways in skeletal muscles. In an initial clinical study, we saw
attenuation of immobilization related muscle atrophy and reduced
intramuscular fat infiltration in healthy subjects receiving our
product candidate, AXA2678."
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 Studies
Each of the company’s ongoing clinical studies are being
conducted as non-investigational new drug (IND) application
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 AXA1125/1957, subsequent 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 and
News” section. Accordingly, investors should monitor such portions
of the company’s website, in addition to following its press
releases, SEC filings and public conference calls and webcasts.
About Axcella
Axcella is a clinical-stage biotechnology company focused on
leveraging endogenous metabolic modulators (EMMs) to pioneer a new
approach for treating complex diseases and improving health. 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 development potential of the Company’s product
candidates, including AXA2678, potential expansion into new health
or therapeutic fields, the ability of endogenous metabolic
modulators to target and impact dysregulated metabolism and health,
including key metabolic pathways in skeletal muscles, and the
potential protection that granted patents provide for the Company’s
product candidates, including AXA2678 . 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
breadth of the company’s pipeline of product candidates, the
strength of the development platform, the efficiency of the
company’s discovery and development approach, the clinical
development and safety profile of product candidates and their
health or therapeutic potential, whether and when, if at all,
product candidates will receive approval from the U.S. Food and
Drug Administration and for which, if any, indications, competition
from other biotechnology companies, the company’s liquidity, its
ability to successfully develop product candidates through current
and future milestones on the anticipated timeline, if at all, 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 and Quarterly
Reports on Form 10-Q and other 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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version on businesswire.com: https://www.businesswire.com/news/home/20200407005011/en/
Company/Investor Contact Jason Fredette
jfredette@axcellahealth.com 857-320-2236 Media Contact Azeem
Zeekrya HDMZ azeem.zeekrya@hdmz.com 312-506-5244
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