AXA1125 demonstrates meaningful reductions in
key measures of liver metabolism, inflammation, and fibrosis
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 the publication of results from the company’s
AXA1125-003 clinical study in The American Journal of
Gastroenterology entitled “Safety, Tolerability, and Biologic
Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty
Liver Disease.” Based on the positive findings from this study,
Axcella recently initiated its EMMPACT℠ Phase 2b clinical trial of
AXA1125 in patients with biopsy-confirmed nonalcoholic
steatohepatitis (NASH).
“As our largest clinical investigation completed to date,
AXA1125-003 served as an important confirmation of AXA1125’s
potential to generate meaningful benefits for patients with NASH
utilizing a multi-targeted mechanism,” says Dr. Alison Schecter,
Axcella’s President of Research and Development. “We are pleased to
share data in this important publication to broaden awareness about
this EMM composition’s potential to serve as a compelling
first-line treatment for NASH. On behalf of our team, I would like
to thank the participants who took part in the study.”
AXA1125-003 was a placebo-controlled, randomized, multi-arm
clinical study that enrolled 102 subjects with presumed NASH and
assessed the impact of AXA1125 and AXA1957 on safety, tolerability
and effects on structures and functions of the liver, as measured
by a comprehensive panel of imaging and soluble biomarkers related
to metabolism, inflammation, and fibrosis. Study subjects were
stratified based on the presence or absence of type 2 diabetes.
Results from the study showed that AXA1125 and AXA1957 were
generally well-tolerated, with sustained reductions noted for both
product candidates versus placebo in key biomarkers of metabolism,
inflammation and fibrosis over 16 weeks. Overall, as compared to
placebo, AXA1125 demonstrated larger and more consistent reductions
in clinically relevant biomarkers than AXA1957. Among subjects
receiving AXA1125, 39% achieved a ≥30% relative reduction in liver
fat content (MRI-PDFF), 39% achieved a ≥17 U/L reduction in alanine
aminotransaminase (ALT; a marker of inflammation), and 35% achieved
a ≥80 mSec reduction in corrected T1 (cT1; a marker of fibrosis).
Among subjects with type 2 diabetes receiving AXA1125, a greater
proportion achieved each of these thresholds. Emerging evidence
suggests that these thresholds of activity increase the likelihood
of histopathological improvement in NASH subjects. Notably, the
above results were seen without impacting mean body weight or serum
lipids.
Initiated in April 2021, EMMPACT℠ is an ongoing randomized,
double-blind, placebo-controlled, multi-center Phase 2b clinical
trial that is evaluating the efficacy and safety of AXA1125 in
patients with biopsy-confirmed F2/F3 NASH. Approximately 270
patients are being enrolled and randomized 1:1:1 to receive either
45.2 or 67.8 grams per day of AXA1125 or a matched placebo in two
divided doses for 48 weeks, with a four-week safety follow-up
period. Patients are stratified based on the presence or absence of
type 2 diabetes. Additional information can be found on
https://clinicaltrials.gov/ via the identifier NCT04880187.
About Endogenous Metabolic Modulators
(EMMs) EMMs are a broad family of naturally occurring
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 underlying causes of various complex diseases and
improve health.
About Axcella’s Clinical
Development Each of the clinical investigations that the
company has completed to date 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 and when Axcella decides to develop a product candidate
as a potential therapeutic, as is the case with AXA1665 and
AXA1125, the company will seek an IND to enable the initiation of
“clinical trials” in patients.
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 this portion 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 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. 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
AXA1125 and the company’s ability to enroll its EMMPACT clinical
trial in a timely manner. 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 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 trials of AXA1665 and AXA1125,
other potential impacts of COVID-19 on the company’s business and
financial results, including with respect to its ability to raise
additional capital and operational disruptions or delays, changes
in law, regulations, or interpretations and enforcement of
regulatory guidance, whether data readouts support the company’s
clinical trial plans and timing, clinical trial design and target
indications for AXA1665 and AXA1125, the clinical development and
safety profile of AXA1665 and AXA1125 and their therapeutic
potential, whether and when, if at all, the company’s product
candidates will receive approval from the FDA or other comparable
regulatory authorities, potential competition from other biopharma
companies in the company’s target indications, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210816005130/en/
Company Jason Fredette jfredette@axcellahealth.com (857)
320-2236
Axcella Health (NASDAQ:AXLA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axcella Health (NASDAQ:AXLA)
Historical Stock Chart
From Apr 2023 to Apr 2024