Axcella Announces Patent Issuances Covering AXA1665
17 June 2020 - 10:00PM
Business Wire
- Both of Axcella’s lead product candidates, AXA1665 and AXA1125,
now covered under U.S. patents for composition of matter and
methods of use
- Expansion of Axcella’s patent estate continues
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 two new patents: U.S.
Patent 10,682,325 and U.S. Patent 10,660,870. These are the first
patents related to Axcella’s family of applications for AXA1665,
the company’s product candidate for the reduction in risk of overt
hepatic encephalopathy recurrence.
U.S. Patent 10,682,325 covers the composition of AXA1665 as well
as other related EMM compositions. U.S. Patent 10,660,870 focuses
on methods of use for these EMM compositions in treating a liver
disease or disorder involving hyperammonemia and/or muscle
wasting.
“Axcella’s goal is to build the world’s leading portfolio of EMM
compositions, backed by strong intellectual property,” said Bill
Hinshaw, President and Chief Executive Officer of Axcella. “Over
the course of the past 18 months, we have grown our number of
patent families to 19, covering both our product candidates as well
as our platform. We also have more than tripled our number of
patent applications to nearly 200 and received our first six patent
issuances covering AXA1665, AXA1125, AXA4010 and AXA2678. These
accomplishments position us well as we approach potential advanced
clinical trials for our lead candidates, AXA1665 and AXA1125.”
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 clinical studies to date, including
AXA1125-003, 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 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 characteristics, competitive position and development
potential of the company’s EMM product candidates and its platform,
the coverage that the company’s expanded patent portfolio provides
to its product candidates and platform and the potential to
approach advanced clinical trials for AXA1665 and AXA1125. 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 any future
challenges to the company’s patents, the scope of and ability to
maintain patent protection, the ability of the patent portfolio to
protect the company’s product candidates and platform, the
potential impacts of COVID-19 on our business and financial
results, whether data readouts and/or U.S. Food and Drug
Administration feedback support our plans and timing for IND
filings, clinical trial design and target indications for AXA1665
and AXA1125, the clinical development and safety profile of the
company’s product candidates and their health or therapeutic
potential, 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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version on businesswire.com: https://www.businesswire.com/news/home/20200617005082/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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