ANAVEX2-73 demonstrates desirable PK/PD properties,
describing the relationship between drug concentration and the
effect observed
Anavex Life Sciences Corp. (Nasdaq:AVXL) today announced
pharmacokinetic (PK) and pharmacodynamic (PD) data for ANAVEX2-73
from its positive Phase 2a study in mild-to-moderate Alzheimer’s
disease patients. ANAVEX2-73 targets the sigma-1 receptor, which
regulates neuroplasticity and cellular homeostasis. Anavex
previously reported the Phase 2a trial successfully achieved both
primary and secondary endpoints at the pre-specified 57-week
analysis.
Data announced today establishes a clear concentration-effect
relationship between ANAVEX2-73 and study measurements. These
measures obtained from all patients during 57 weeks include
cognitive and functional scores as well as a biomarker signal of
brain activity. Additionally, ANAVEX2-73 activity appears to be
enhanced by its active metabolite (ANAVEX19-144), which also
targets the sigma-1 receptor with a half-life approximately twice
as long as the parent molecule.
“I welcome such a thorough analysis of data before moving into a
Phase 2/3. The intriguing ANAVEX2-73 data shown thus far
exemplifies a precision medicine approach, to my knowledge, the
first of its kind to broaden the scope of drug development in
Alzheimer’s disease and other central nervous system diseases,”
said George Perry, PhD, Dean of the College of Sciences at The
University of Texas at San Antonio and editor-in-chief of the
Journal of Alzheimer’s Disease.
The Company is identifying the best responders to ANAVEX2-73 by
using Ariana Pharma’s KEM® advanced Artificial Intelligence
technology. This cutting edge trial analysis will be used to more
effectively design the upcoming Phase 2/3 clinical study, raising
the odds of late stage trial success.
“We continue to be encouraged by the data from our Phase 2a
clinical trial for ANAVEX2-73,” said Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. “We believe that
through a systematic analysis of ANAVEX2-73 we might be able to
increase the potential impact ANAVEX2-73 may have on this
devastating condition.”
On the conference call scheduled for this morning, Christopher
U. Missling, PhD, President and Chief Executive Officer of Anavex
will be joined by Professor George Perry, PhD and Mohammad Afshar,
MD, PhD, President and CEO of Ariana Pharma to discuss new findings
from the ANAVEX2-73 Phase 2a trial. Further data will be presented
at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in
November 2017.
Conference call and webcast information
Anavex will host a conference call at 8:30 a.m. ET today,
October 12, 2017. The call will be webcast live at
http://www.wsw.com/webcast/cc/avxl2 and slides are accessible
through the investor relations section of the Company's website at
www.anavex.com. To join the call live via telephone dial
1-866-866-1333 within the United States or 1-404-260-1421 from
outside the United States. A replay of the call will also be
available for a period of three months through the Company's
website shortly after the call.
About ANAVEX®2-73 Phase 2a Clinical Study
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consisted
of two parts and a total of 32 mild-to-moderate Alzheimer’s
patients. PART A was a simple randomized, open-label, two-period,
cross-over between oral (30mg/50mg) and IV (3mg/5mg)
administration, adaptive trial lasting up to 5 weeks for each
patient. PART B was an open-label extension for an additional 52
weeks. Initially planned for 26 weeks, PART B was extended to 52
weeks as a result of requests from patients and caregivers.
The primary endpoint of the Phase 2a trial was safety,
tolerability and maximum tolerated dose (MTD) of ANAVEX2-73, which
had shown potential in preclinical studies to prevent, halt and/or
reverse the course of the disease. Secondary endpoints included
dose response, bioavailability, and exploratory cognitive as well
as functional measures using Mini Mental State Examination (MMSE)
and evaluation of Alzheimer’s Disease Co-operative Study –
Activities of Daily Living Inventory (ADCS-ADL), as well as
Cogstate test battery and biomarker EEG/ERP.
About Ariana Pharma
Ariana® Pharma is a leading digital health Company focused on
developing advanced therapeutic decision support systems. Ariana’s
innovative clinical data analysis and diagnostic testing solutions
help the healthcare sector better adapt patient treatments to
individual biological characteristics. Ariana Pharma’s KEM®
technology enables personalization of therapies, improves the
efficacy and safety of patient treatment, reduces risks and drug
development costs, and accelerates time to market. KEM® is the only
FDA-tested technology that systematically explores combinations of
biomarkers, producing more effective biomarker signatures for
precision medicine. Ariana has developed Onco KEM®, the most
advanced, clinically tested, oncology treatment selection system.
Founded in 2003 as a spin-off of the Institut Pasteur, Paris,
France, the company opened a subsidiary in the United States in
2012. Further information is available at www.arianapharma.com.
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,
other central nervous system (CNS) diseases, pain and various types
of cancer. Anavex’s lead drug candidate, ANAVEX®2-73, recently
completed successfully a Phase 2a clinical trial for Alzheimer’s
disease. 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. It has 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 has awarded
Anavex a research grant to develop ANAVEX®2-73 for the treatment of
Parkinson’s disease to fully fund a preclinical study, which could
justify moving ANAVEX®2-73 into a Parkinson’s disease clinical
trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic
receptors, is a promising preclinical drug candidate demonstrating
disease modifications against the major Alzheimer’s hallmarks in
transgenic (3xTg-AD) mice, including cognitive deficits, amyloid
and tau pathologies, and also with beneficial effects on
neuroinflammation and mitochondrial dysfunctions. 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:
Clayton RobertsonThe Trout Group(646)
378-2900crobertson@troutgroup.com
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