Anavex Life Sciences Presents New Clinical Data Identifying Gut Microbiota Biomarkers Associated with Improved Clinical Respo...
July 17 2019 - 11:45AM
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative
and neurodevelopmental diseases including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today reported results from a study evaluating the
gut microbiota of patients in the ongoing ANAVEX®2-73 Phase 2a
extension study of ANAVEX®2-73, a selective sigma-1 receptor
agonist.
“This is the first gut microbiota DNA sequencing
analysis of Alzheimer’s disease patients treated with ANAVEX®2-73,
which might help to identify potential biomarkers of response for
ANAVEX®2-73,” said Christopher U. Missling, PhD, President and
Chief Executive Officer of Anavex. “We continue to advance the
ANAVEX®2-73 Alzheimer’s disease program through the ongoing Phase
2b/3 Alzheimer’s disease clinical study1 and in other ongoing
ANAVEX®2-73 clinical trials focused on serious neurology diseases
with high unmet needs, including Rett syndrome2 and Parkinson’s
disease dementia3.”
The analysis was conducted using Ariana Pharma’s
KEM® Artificial Intelligence, an FDA-tested technology to
systematically explore combinations of biomarkers. Results revealed
that patients treated with ANAVEX®2-73 had high levels of two gut
microbiota families, Ruminococcaceae and Porphyromonadaceae, which
were associated with improved activities of daily living (ADCS-ADL)
at week 148 (p<0.01 and p<0.04, respectively).
Communication between gut microbiota and the
brain has been shown to be a critical requirement of a healthy
brain function. The reduction in gut microbiota diversity has
become one of the hallmarks of aging, and disturbances in its
composition are associated with several age-related neurological
conditions, including Alzheimer’s disease. These changes in the gut
microbiota composition induce increased permeability of the gut
barrier and immune activation leading to systemic inflammation,
which in turn may impair the blood-brain barrier and promote
neuroinflammation, neural injury, and ultimately
neurodegeneration.4
Numerous pre-clinical studies demonstrate
beneficial effects of SIGMAR1 (S1R) agonists on neuroinflammation,
including with ANAVEX®2-735. The effect might potentially be
reversal of the microbiota imbalances and might have a homeostatic
effect on the brain-gut-microbiota axis.
The oral presentation at AAIC 2019, titled,
Exploring gut microbiota as a source of potential biomarkers:
Initial results from the ANAVEX®2-73 Alzheimer’s disease clinical
study [O4-02-04]6 will be presented by the lead author of the
study, Mohammad Afshar, MD, PhD, CEO of Ariana Pharma, and will be
available at www.anavex.com.
About ANAVEX®2-73-003 Phase 2a Clinical
Study Gut Microbiota ProtocolThe multicenter Phase 2a
clinical trial of ANAVEX®2-73 open-label 208-week study
(ClinicalTrials.gov NCT02756858) was extended after the previous
57-week 32 mild-to-moderate Alzheimer’s disease patients’ study
(ClinicalTrials.gov NCT02244541) was completed. A total of 16
patients consented to the stool sampling, which took place between
week 77 and 109. Abundance of each gut microbiota
genus/family/phylum was assessed using 16S meta-sequencing,
resulting in the analysis of 32,875 operational taxonomic units
(OTU) i.e. microbial species in the human’s gut. A dedicated
bioinformatics pipeline was used for taxonomic classification of
sequences; relative abundances measurement of operational taxonomic
units (OTU) were mapped to phyla, families and genera of gut
microbiota. The full integrated knowledge base, including omic and
clinical parameters, was analyzed using Ariana Pharma’s Artificial
Intelligence platform KEM®. KEM® enables identification and ranking
of biomarkers relating to outcome derived from a small number of
samples, while avoiding overfitting and bias.
About Anavex Life Sciences
Corp.Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases including
Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other
central nervous system (CNS) diseases, pain and various types of
cancer. Anavex’s lead drug candidate, ANAVEX®2-73, recently
completed a successful Phase 2a clinical trial for Alzheimer’s
disease and is currently in clinical studies in Phase 2b/3
Alzheimer’s disease, Phase 2 Parkinson’s disease dementia and two
Phase 2 studies in Rett syndrome. ANAVEX®2-73 is an orally
available drug candidate that restores cellular homeostasis by
targeting sigma-1 and muscarinic receptors. Preclinical studies
demonstrated its potential to halt and/or reverse the course of
Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant,
anti-amnesic, neuroprotective and anti-depressant properties in
animal models, indicating its potential to treat additional CNS
disorders, including epilepsy. The Michael J. Fox Foundation for
Parkinson’s Research previously awarded Anavex a research grant,
which fully funded a preclinical study to develop ANAVEX®2-73 for
the treatment of Parkinson’s disease. ANAVEX®3-71, which targets
sigma-1 and M1 muscarinic receptors, is a promising preclinical
drug candidate demonstrating disease-modifying activity against the
major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD)
mice, including cognitive deficits, amyloid and tau pathologies. In
preclinical trials, ANAVEX®3-71 has shown beneficial effects on
neuroinflammation and mitochondrial dysfunction. Further
information is available at www.anavex.com. You can also connect
with the company
on Twitter, Facebook and LinkedIn.
Forward-Looking
StatementsStatements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
For Further Information:Anavex
Life Sciences Corp.Research & Business DevelopmentToll-free:
1-844-689-3939Email: info@anavex.com
Investors & Media:Email:
ir@anavex.com
Media:Melyssa WeibleElixir
Health Public
Relations201-723-5805mweible@elixirhealthpr.com
1 ClinicalTrials.gov Identifier: NCT037907092
ClinicalTrials.gov Identifier: NCT03758924; ClinicalTrials.gov
Identifier: NCT039414443 ClinicalTrials.gov Identifier:
NCT037744594 Giau, V.V.; Wu, S.Y.; Jamerlan, A.; An, S.S.A.; Kim,
S.; Hulme, J. Gut Microbiota and Their Neuroinflammatory
Implications in Alzheimer’s Disease. Nutrients 2018, 10, 17655 1)
Jia J et al 2018. Front Cell Neurosci. 2018 Sep 20;12:314; 2) Zhao
J et al 2014. Invest. Ophthalmol. Vis. Sci. 55, 3375–3384; 3)
Behensky AA et al 2013. J. Pharmacol. Exp. Ther. 347, 458–467; 4)
Cenci A et al 2016. Presented at World Parkinson Congress; 5) Hall
H et al 2018. Alzheimers Dement. Jun;14(6):811-823; 6)
Allahtavakoli M et al 2011. Brain Res Bull. May 30;85(3-4):219-24;
7) Cogram P et al 2016. Presented at Gordon Research Conference; 8)
Lisak RP et al 2016. Poster presentation at ACTRIMS; 9) Lisak RP et
al 2017. Oral presentation at ECTRIMS6 Frédéric Parmentier, PhD1,
Adrien Etcheto, MSc1, Christopher U Missling, PhD2; Coralie
Williams, MSc1, Mohammad Afshar, MD, PhD1, 1Ariana Pharma, Paris,
France, 2Anavex Life Sciences Corp., New York, NY
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