Poster presentations highlight AXA1125’s
multifactorial activity; potentially differentiating and enhanced
effects in subjects with type 2 diabetes
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 shared details about the company’s poster presentations at
The Liver Meeting® 2020, the Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD), which is
taking place virtually today through November 16, 2020. Both
presentations feature data from AXA1125-003, a placebo-controlled,
randomized clinical study that enrolled 102 subjects with presumed
nonalcoholic steatohepatitis (NASH) to assess the impact of AXA1125
and AXA1957 on safety, tolerability and effects on structures and
functions of the liver for 16 weeks.
“The results of AXA1125-003 were a key milestone for Axcella in
which we were able to demonstrate clinically relevant
multifactorial effects with AXA1125 in subjects with presumed
NASH,” said Manu Chakravarthy, M.D., Ph.D., Axcella’s Chief Medical
Officer and Executive Vice President of Clinical Development. “At
The Liver Meeting this week, we are sharing further data from this
study. Based on AXA1125’s data to date and its multi-targeted
mechanism of action, we believe this candidate is well positioned
to be a first-line NASH therapy with potentially differentiating
effects in type 2 diabetic subjects. We look forward to
investigating its impact on liver histology in our upcoming serial
biopsy Phase 2b clinical trial in patients with biopsy-proven
NASH.”
Abstract 1663 is entitled “Biological Activity of AXA1125 and
AXA1957 on Glucose, Insulin, HOMA-IR, and HbA1c and Measures of
Liver Fat and Fibroinflammation in a Prospective 16-Week
Randomized, Placebo-Controlled Study in Subjects with NAFLD and
Type 2 Diabetes.” This presentation highlights reductions seen in
subjects receiving AXA1125 vs. placebo in markers of metabolism
(MRI-PDFF and HOMA-IR) and fibroinflammation (cT1, ProC3 and FIB-4)
as well as the reduction over time in ALT through 16 weeks.
Additionally, the presentation shows the increased proportion of
subjects receiving AXA1125 vs. placebo that achieved clinically
relevant thresholds of improvement in specific markers,
including:
Threshold
Subjects on Placebo
Subjects on AXA1125
≥30% reduction in MRI-PDFF
8.3%
38.5%
≥17 U/L reduction in ALT
25.0%
38.5%
≥80 mSec reduction in cT1
16.7%
34.6%
≥2 ng/mL reduction in ProC3
33.3%
50.0%
Abstract 1694 is entitled “Safety, Tolerability, and Biological
Activity of AXA1125 and AXA1957 in a Prospective 16-Week
Randomized, Placebo-Controlled Study in Subjects with NAFLD with
and without Type 2 Diabetes.” Focusing on data for subjects with
both presumed NASH and type 2 diabetes (T2D), the presentation
highlights reductions seen in those receiving AXA1125 vs. placebo
in measures of fasting glucose, fasting insulin, HOMA-IR, HbA1C,
MRI-PDFF, ALT, cT1 and ProC3. It also features the increased
proportion of these subjects that achieved clinically relevant
thresholds of improvement in specific markers, including:
Threshold
T2D Subjects on
Placebo
T2D Subjects on
AXA1125
≥30% reduction in MRI-PDFF
0%
54.5%
≥17 U/L reduction in ALT
33.3%
63.6%
≥80 mSec reduction in cT1
33.3%
45.5%
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 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 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. 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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Jason Fredette jfredette@axcellahealth.com 857.320.2236
Axcella Health (NASDAQ:AXLA)
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