- Patient screening underway in the United Kingdom in trial to
assess oral product candidate’s potential to address Long COVID
fatigue and muscle weakness
- Top-line data readout anticipated by mid-2022
Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage
biotechnology company pioneering a new approach to treat complex
diseases using multi-targeted endogenous metabolic modulator (EMM)
compositions, and researchers at the Oxford University Radcliffe
Department of Medicine today announced that patient screening is
now underway in a Phase 2a trial that is investigating AXA1125, an
oral product candidate, as a potential treatment for Long COVID,
also known as Post COVID-19 Condition and post-acute sequelae of
SARS-COV-2 infection (PASC).
“There already has been a tremendous amount of interest in
participating in this trial among patients suffering from Long
Covid fatigue,” said lead researcher Dr. Betty Raman, British Heart
Foundation Oxford Centre of Research Excellence Clinical Transition
Intermediate Fellow. “This is not surprising given the sheer number
of patients impacted by this syndrome, the life-changing symptoms
that they are experiencing and the complete absence of treatment
options today. We are keen to evaluate AXA1125’s impact on the
mitochondria and muscle function and its potential to improve
functional outcomes for patients who are in desperate need.”
The Phase 2a is a randomized, double-blind, placebo-controlled
trial that is evaluating the efficacy and safety of AXA1125 in
patients with exertional fatigue related to Long COVID.
Approximately 40 patients in the United Kingdom will be enrolled
and randomized evenly to receive either 67.8 grams per day of
AXA1125 or a matched placebo in two divided doses for 28 days, with
a one-week safety follow-up period.
“There is mounting evidence suggesting that infection with the
COVID-19 virus can impair the mitochondria’s ability to act as the
‘powerhouse of the cell,’ manifesting in Long COVID fatigue and
muscle weakness,” said Dr. Alison Schecter, President of R&D at
Axcella. “Our preclinical and clinical findings to date demonstrate
that AXA1125 holds the potential to improve multiple aspects of
mitochondrial biology, including increasing energetics and reducing
inflammation. This provides us with hope that we can make a real
difference for tens of millions of patients suffering from this
debilitating condition.”
The primary endpoint in this Phase 2a trial is the change from
baseline to Day 28 in phosphocreatine (PCr) recovery time as
measured by 31-phosphorus magnetic resonance spectroscopy (pMRS).
In past clinical trials, this highly sensitive and well-established
measure of mitochondrial function has been correlated with the
six-minute walk test, which has been a registrational endpoint in
other conditions involving fatigue, such primary pulmonary
hypertension and exertional angina. Key secondary endpoints in the
Phase 2a trial include lactate levels (a serum marker of
mitochondrial dysfunction), six-minute walk test, fatigue scores,
and safety and tolerability.
Top-line data are expected to be reported from the Phase 2a
trial in mid-2022.
More than 270 million cases of COVID-19 have been reported
worldwide to date, and a recent study estimates that nearly a
quarter of Americans who contract COVID-19 experience Long COVID
symptoms. Research indicates that fatigue is the most common of
these symptoms, impacting a majority of Long COVID patients.
About AXA1125
AXA1125 is a proprietary multi-targeted EMM composition
consisting of five amino acids and an amino acid derivative that
works via multiple biological pathways. Preclinical and clinical
data have shown this oral product candidate’s potential to increase
fatty acid oxidation, ATP production, ketogenesis and mitochondrial
bioenergetics, contributing to meaningful reductions in key markets
of liver fat, insulin resistance, inflammation, and fibrosis.
AXA1125 is currently being investigated in the EMMPACT Phase 2b
clinical trial in nonalcoholic steatohepatitis (NASH) (NCT04880187)
and a Phase 2a clinical trial in Long COVID (NCT05152849).
About the University of Oxford and The
Radcliffe Department of Medicine
Oxford University has been placed number 1 in the Times Higher
Education (THE) World University Rankings for the sixth year
running, and at the heart of this success is the University’s
ground-breaking research and innovation. Oxford is world-famous for
research excellence and home to some of the most talented people
from across the globe. The University’s work helps the lives of
millions, solving real-world problems through a huge network of
partnerships and collaborations. The breadth and interdisciplinary
nature of our research sparks imaginative and inventive insights
and solutions. Through its research commercialization arm, Oxford
University Innovation, Oxford is the highest university patent
filer in the UK and is ranked first in the UK for university
spinouts, having created more than 200 new companies since 1988.
Over a third of these companies have been created in the past three
years.
The Radcliffe Department of Medicine (RDM) is one of the two
main departments of medicine at the University of Oxford and aims
to tackle some of the world’s biggest health challenges by
integrating innovative basic biology with cutting edge clinical
research. The RDM has internationally renowned programs in a range
of areas including cardiovascular sciences, diabetes and
endocrinology, immunology, hematology and pathology.
https://www.rdm.ox.ac.uk/.
About Axcella Therapeutics (Nasdaq:
AXLA)
Axcella is a clinical-stage biotechnology company pioneering a
new approach to treat complex diseases using endogenous metabolic
modulator (EMM) compositions. The company’s product candidates are
comprised of EMMs and derivatives that are engineered in distinct
combinations and ratios to restore cellular homeostasis in multiple
key biological pathways and improve cellular energetic efficiency.
Axcella’s pipeline includes lead therapeutic candidates in Phase 2
development for the reduction in risk of overt hepatic
encephalopathy (OHE) recurrence, the treatment of Long COVID, and
the treatment of non-alcoholic steatohepatitis (NASH). The
company’s unique model allows for the evaluation of its EMM
compositions through non-IND clinical studies or IND clinical
trials. For more information, please visit www.axcellatx.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, the potential for it to address patients’
unmet needs, and the timing of the company’s clinical trial
readouts. 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211215005548/en/
University of Oxford Dr. Charvy Narain
charvy.narain@rdm.ox.ac.uk 01865 234648
Axcella Therapeutics Jason Fredette
jfredette@axcellatx.com (857) 320-2236
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