Presentation Includes New Data from Phase
2a Long-Term Extension Cohort
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, other
central nervous system (CNS) diseases, pain and various types of
cancer, today presented new clinical pharmacokinetic (PK) and
pharmacodynamic (PD) data for ANAVEX2-73 in a late-breaking oral
presentation at the 2017 Clinical Trials on Alzheimer’s Disease
(CTAD) Meeting.
Data presented include new results from the Phase 1 study
(ANAVEX®2-73-001), the Phase 2a study (ANAVEX®2-73-002), and data
from the first year of the Phase 2a long-term extension study
(ANAVEX®2-73-003).
At 109 weeks and halfway into the long-term extension Phase 2a
study ANAVEX®2-73-003, data from the cohort of patients with the
highest ANAVEX2-73 concentrations point towards the continued
ability of the medication to stop the decline in the exploratory
secondary endpoints cognition (MMSE) and function (ADCS-ADL). At 57
weeks, this cohort had demonstrated improvement of the measures
MMSE and ADCS-ADL compared to baseline. For the primary endpoint,
ANAVEX2-73 demonstrated continued favorable safety and tolerability
through 109 weeks.
“We are cautiously optimistic about the promising results of
ANAVEX2-73 observed in patients who have received the drug for over
two years,” said Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex. “We are committed to advancing
ANAVEX2-73, utilizing all relevant scientific knowledge we can
learn, in hopes of helping those affected by the disease.”
Additionally, clinical data from 54 subjects from the Phase 1
(ANAVEX®2-73-001) and the Phase 2a (ANAVEX®2-73-002) trials were
analyzed including using formal concept analysis (FCA), non-linear
mixed effect (NLME) modeling and non-compartmental analysis
methods.
Data analysis demonstrates:
- Strong drug concentration / response relationship for
exploratory secondary endpoints cognition (MMSE) and function
(ADCS-ADL). Drug concentration in the upper tertile increased the
probability of improved MMSE score 2.1-fold (110%) during 57 weeks.
Also, higher drug concentration increased the probability of
improved ADCS-ADL score 1.6-fold (67%) during the same period.
- Alzheimer’s patients with milder disease stage (baseline MMSE
>20) tended to respond better to ANAVEX2-73 than patients with
more advanced disease stage (baseline MMSE <20).
- No difference in the pharmacokinetics of ANAVEX2-73 was
observed between women and men.
- ANAVEX2-73 administration does not prolong QTc interval.
This data provide support to proceed with the clinical
development of ANAVEX2-73 for Alzheimer’s disease in a focused
Phase 2/3 study using the precision medicine paradigm, including
DNA whole exome, RNA expression and gut microbiome
characterization. Further clinical studies in other indications,
such as Rett syndrome and Parkinson’s disease are under development
utilizing the translational potential of precision medicine
approach of ANAVEX2-73.
ANAVEX2-73 is a novel, orally available sigma-1 receptor
agonist. Sigma-1 receptor, an emerging therapeutic target in
Alzheimer’s disease and other central nervous system disorders, has
been shown to reduce cellular stress and regulate neuroplasticity
and cellular homeostasis. The Company previously reported that the
Phase 2a (ANAVEX®2-73-002) trial successfully achieved both primary
and secondary endpoints.
Presentation Details:
Title: Clinical Pharmacokinetics and Pharmacodynamics
Characterization of ANAVEX2-73 for Designing a Phase 2/3 Study in
Mild-to-Moderate Alzheimer’s Disease
Date and Time: Saturday November 4th, 2017 at 3:30 pm ET
The slides are accessible through the investor relations section
of the Company's website at www.anavex.com.
About ANAVEX®2-73-002 Phase 2a Clinical Study
(ClinicalTrials.gov NCT02244541)
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 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 the 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 ANAVEX®2-73-003 Phase 2a Clinical Study
(ClinicalTrials.gov NCT02756858)
The multi-center Phase 2a clinical trial of ANAVEX 2-73 consists
of an open-label extension for an additional 104 weeks, allowing
for the collection of potential safety data for ANAVEX 2-73
cumulatively over three years.
The new 104-week (two-year) extension of the multi-center Phase
2a clinical trial of ANAVEX 2-73 will follow mild-to-moderate
Alzheimer’s patients who have already completed 52 weeks in PART B
of the study. Every three months, patients will be scheduled
for physician visits to assess primary and secondary endpoints.
The primary endpoint of the new Phase 2a trial is to establish
continued safety and tolerability of ANAVEX 2-73. Secondary
endpoints are exploratory cognitive as well as functional measures
using the Mini Mental State Examination (MMSE) and evaluation of
Alzheimer’s Disease Co-operative Study – Activities of Daily Living
Inventory (ADCS-ADL), respectively.
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 a successful 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. The grant fully funds 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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