Poster presentation contains data demonstrating
AXA1125’s multifactorial effects on markers of metabolism,
inflammation and fibrosis in subjects with NAFLD
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, announced that data are being presented today in a
late-breaker poster regarding key findings from its AXA1125-003
clinical study by Stephen A. Harrison, M.D., Medical Director of
Pinnacle Clinical Research in San Antonio, TX, visiting professor
of Hepatology at the University of Oxford, UK. The poster
presentation is entitled “Multifactorial Effects of AXA1125 and
AXA1957 Observed on Markers of Metabolism, Inflammation and
Fibrosis: A 16-Week Randomized Placebo-Controlled Study in Subjects
With Nonalcoholic Fatty Liver Disease (NAFLD) With and Without Type
2 Diabetes (T2D).”
“Based on the multifactorial effects seen in initial clinical
investigations and its well-tolerated profile to date, AXA1125 is
among the most intriguing candidates in development for
nonalcoholic steatohepatitis (NASH),” said Dr. Harrison. “Notable
reductions in virtually all non-invasive biomarkers – including
liver fat content (MRI-PDFF), alanine aminotransferase (ALT) and
corrected T1 (cT1) – were seen in subjects receiving AXA1125 versus
placebo in the 003 clinical study. Interestingly, mean reductions
in these measures were even greater among subjects with T2D,
providing the potential for a highly differentiated profile within
the NASH field.”
AXA1125-003 was a placebo-controlled, randomized, multi-arm
clinical study assessing the impact of AXA1125 and AXA1957 on
safety, tolerability and effects on structures and functions of the
liver. A total of 102 adult subjects with presumed NASH were
enrolled and dosed in a 2:2:2:1 ratio to receive AXA1125, one of
two AXA1957 doses, or placebo administered twice daily for 16
weeks. Study subjects were stratified based on the presence or
absence of T2D, with approximately 40 percent of the subjects
having T2D.
Highlights from the presentation include:
- The AXA1125 study arm consistently achieved numerically greater
reductions from baseline in biomarkers of liver fat and
fibroinflammation versus placebo, with AXA1957 showing activity in
a number of key biomarkers, but with less consistent directional
change than AXA1125
- A reduction from baseline was seen in the AXA1125 arm compared
with placebo at weeks 8 and 16 in:
- Liver fat biomarker MRI-PDFF
- HOMA-IR
- ALT
- CK-18 M65
- ProC3
- cT1
- In the AXA1125 arm, 39 percent of subjects achieved a ≥30
percent relative reduction in MRI-PDFF, 39 percent achieved a ≥17
U/L reduction in ALT from baseline, and 54 percent achieved a ≥40
millisecond absolute reduction in cT1
- AXA1125 and AXA1957 were both generally well tolerated in the
study, with low rates of discontinuations and with all
product-emergent adverse events being mild or moderate
As announced earlier this year in conjunction with Axcella’s
top-line data announcement, the company plans to advance AXA1125
into a Phase 2b clinical trial in adult NASH in the first half of
2021.
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 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 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 and development potential of the
company’s EMM product candidates and the company’s characterization
of the results from its clinical studies and future clinical
trials, including for AXA1125, the company’s anticipated program
milestones, including the design, status and timing of the planned
Phase 2b clinical trial of AXA1125 in adult NASH, the subject and
timing of the company’s planned interactions with the FDA,
including the timing of IND submissions, and the potential of the
company’s product candidates to impact health and/or disease,
including AXA1125’s potential in NASH. 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
submission 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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version on businesswire.com: https://www.businesswire.com/news/home/20200827005115/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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