- 60 subjects enrolled in AXA1665-002
- Top-line data expected in mid-2020
- IND submission for overt hepatic encephalopathy and initiation
of potential registrational Phase 2b/3 clinical trial planned for
second half of 2020
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 that it has completed subject enrollment in
its ongoing AXA1665-002 clinical study. This 12-week,
placebo-controlled, randomized study is investigating the safety,
tolerability and physiological impact of two doses of AXA1665 in 60
subjects with mild and moderate hepatic insufficiency. Ongoing
safety monitoring in this study supports that both doses of AXA1665
have been well tolerated to date. Additionally, a comprehensive
panel of biomarkers are being measured related to amino acid
metabolism, ammonia, muscle structure and function including body
composition, and neurocognition.
“We continue to be pleased by the speed at which we have been
able to enroll subjects in our clinical studies, including
AXA1665-002. We believe this is due in large part to the motivation
of investigators to work with us and their intrigue about the
potential impact of our EMM compositions,” said Bill Hinshaw,
President and CEO of Axcella. “We look forward to completing this
ongoing clinical study and sharing top-line data in mid-2020.
Assuming supportive data and FDA feedback, we plan to initiate an
IND-enabled potential Phase 2b/3 registrational clinical trial in
the second half of 2020. We believe EMMs may benefit many people
who are afflicted by complex diseases, including overt hepatic
encephalopathy (OHE), which is a condition for which patients still
have limited treatment options.”
Axcella plans to investigate AXA1665 as an oral product
candidate for overt hepatic encephalopathy, a disease that is
associated with amino acid imbalance, dysregulated ammonia
metabolism, and muscle wasting.
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 Ongoing 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 prevention of recurrent overt
hepatic encephalopathy (OHE). 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 EMM product
candidates, including AXA1665, to impact dysregulated metabolism
and benefit individuals with complex diseases, the potential of
AXA1665 to benefit patients with OHE, the timing of the company’s
ongoing clinical studies and planned IND-enabled clinical trials
and the timing of receipt and disclosure of data from the same. 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 and potential uses of the
company’s pipeline of product candidates, including the potential
for AXA1665 to benefit OHE patients, whether planned data readouts
and disclosures are positive and support our believes regarding
EMMs and AXA1665’s potential ability to benefit not just healthy
but also diseased patients, including patients with OHE, and the
planned timing of our disclosures regarding data readouts, whether
data readouts and/or FDA feedback support our planned timing for an
IND filing, clinical trial design and target indication for
AXA1665, the strength of the AXA Development Platform, the
efficiency of the company’s discovery and development approach, the
clinical development and safety profile of the company’s product
candidates and their health or therapeutic potential, whether and
when, if at all, the company’s product candidates will receive
approval from the U.S. Food and Drug Administration, or other
comparable regulatory authorities, 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 non-IND clinical studies not
being representative of future results, and other risks identified
in the company’s SEC filings, including Axcella’s 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/20200226005116/en/
Company/Investor Contact Jason Fredette
jfredette@axcellahealth.com 857.320.2236
Media Contact Azeem Zeekrya HDMZ
azeem.zeekrya@hdmz.com
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