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 disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced Late Breaking Oral Communication at
CTAD 2019.
Interim 2-Year (104)-Week) data from the Phase
2a ANAVEX®2-73 (blarcamesine) extension study, with Alzheimer’s
disease patients followed for up to five years, will be presented
at the 12th Clinical Trials On Alzheimer's Disease (CTAD) 2019
Conference in San Diego, CA (December 4-7, 2019).
“These results confirm the rationale to advance
the ANAVEX®2-73 (blarcamesine) Alzheimer’s disease program through
the ongoing Phase 2b/3 Alzheimer’s disease clinical study1,” said
Christopher U. Missling, Ph.D., Chief Executive Officer of Anavex.
“The data also establishes the findings of two further gut
microbiota family biomarkers linked to improved response with
ANAVEX®2-73 (blarcamesine).”
FDA’s Framework for Real World Evidence document
released in December 2018 demonstrates how Real World Evidence can
be incorporated into regulatory decision-making. This framework was
applied to the study of ANAVEX®2-73 (blarcamesine), a selective
sigma-1 receptor (SIGMAR1) agonist that was investigated in an
open-label 57-week Phase 2a study of Alzheimer’s Disease (AD)
patients (N=32) showing a favourable safety profile (NCT02244541)
and was further extended by 208 weeks (NCT02756858). A hypothesis
free data-driven analysis using Formal Concept Analysis Machine
Learning as implemented in Knowledge Extraction and Management
(KEM) software platform was used to identify exploratory efficacy
and patient selection biomarkers including SIGMAR1 p.Q2P
(rs1800866).
The goal of this study was to evaluate the
efficacy of ANAVEX®2-73 (blarcamesine), measured by Mini Mental
State Examination (MMSE) and comparing treated patients with an
external control AD cohort of patients from the Alzheimer’s Disease
Neuroimaging Initiative (ADNI) database over a 104-week period.
Individual patient-level data (IPD) was obtained
from the ADNI (National Institutes of Health Grant U01 AG024904)
and DOD ADNI (Department of Defense award number W81XWH-12-2-0012).
ADNI is a longitudinal multicenter study designed to develop
clinical, imaging, genetic, and biochemical biomarkers for the
early detection and tracking of AD. A total of 1891 patients were
followed in this study including 345 AD patients with available
MMSE scores.
Propensity score matching (PSM) was applied
using Linear Mixed Effects (LME) models including descriptors of
age, sex, SIGMAR1 p.Q2P carrier status, APOE4 allele and MMSE at
baseline to select patients with similar baseline characteristics
and any confounding factors between AD patients in the Phase 2a
ANAVEX®2-73 (blarcamesine) cohort and AD patients from the ADNI
control cohort.
Change in MMSE score from baseline at week 104
of matched cohorts was assessed. It showed that ANAVEX®2-73
(blarcamesine) high dose cohort had a significantly lower MMSE
decline (-1.1) compared to the ADNI control cohort (-4.4) at week
104 (p < 0.01).
The presentations at CTAD 2019
include:
Oral presentation [LB20]: Novel
analytics framework for augmenting single-arm Phase 2a open label
trials with Real-World external control data: Application to the
Blarcamesine (ANAVEX®2-73) study in Alzheimer’s disease matched
with propensity corrected patients from Alzheimer’s Disease
Neuroimaging Initiative (ADNI) exploring treatment effect on
cognition at interim two-year (104-Week) timepoint2
Poster presentation [P84]: Gut
Microbiota and Response to Blarcamesine (ANAVEX®2-73) in
Alzheimer’s Disease Patients: Abundance of Lachnospiraceae and
Enterobacteriaceae Families as Potential Biomarker of Response from
a 2-Year Study Interim Clinical Data Analysis using KEM Artificial
Intelligence3
The presentations will be accessible through the
investor relations section of the Company's website at
www.anavex.com.
About ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 activates the Sigma-1 receptor (S1R)
protein, which serves as a molecular chaperone and functional
modulator involved in restoring homeostasis. S1R activation has
demonstrated ability to reduce key pathophysiological signs of
Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and
increased inflammation. In a Phase 2a Alzheimer’s disease (AD)
study, ANAVEX®2-73 (blarcamesine) has shown dose dependent
improvement in exploratory endpoints of cognition (MMSE) and
function (ADCS-ADL). Full genomic analysis of ANAVEX®2-73 Phase 2a
AD patients was performed. A 48-week Phase 2b/3 study of
ANAVEX®2-73 (blarcamesine) in 450 patients with early Alzheimer’s
disease is ongoing.
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 disorders 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 (blarcamesine),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s
disease. ANAVEX®3-71, which targets sigma-1 and 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 mitochondrial
dysfunction and neuroinflammation. Further information is available
at www.anavex.com. You can also connect with the company
on Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements 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
1 ClinicalTrials.gov Identifier: NCT03790709
2 C. Williams1, N. Sritharan1, F. Parmentier1, F. Goodsaid2, C.
U. Missling3, M. Afshar1; (1) Ariana Pharma, Paris, France; (2)
Regulatory Pathfinders LLC, San Francisco, CA; (3) Anavex Life
Sciences Corp., New York, NY
3 C. Williams1, F. Parmentier1, A. Etcheto1, C. U. Missling2, M.
Afshar1; (1) Ariana Pharma, Paris, France; (2) Anavex Life Sciences
Corp., New York, NY
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