Sustained Response Through 31 Weeks for both Cognitive (MMSE) and Functional (ADCS-ADL) Measures
NEW YORK, NY – July 27, 2016 – 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 announced efficacy data through 31 weeks from the ongoing ANAVEX 2-73 Phase 2a study in mild-to-moderate Alzheimer’s patients presented in the second of two posters at the Alzheimer’s Association International Conference® (AAIC) 2016.
Overall, efficacy results demonstrate what appears to be a converging and consistent response for all quantitative endpoints through 31 weeks, including cognitive and functional measures: Mini Mental State Examination (MMSE), Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL), Cogstate and electroencephalographic activity and event-related potentials (EEG/ERP).
In a disease state where progression is invariable over time, a sustained or stable MMSE and ADCS-ADL score is considered a positive outcome.
“The demonstration of an extended period of both cognitive and functional stability out to 31 weeks in a patient population that would normally be expected to experience ongoing cognitive decline is an encouraging milestone in the development of ANAVEX 2-73. The 31-week data also validates the earlier observation of improvements on tasks within the Cogstate battery. The specificity and consistency of these benefits suggest that ANAVEX 2-73 can sustain activation of attentional and working memory functions with repeated dosing in Alzheimer’s disease,” said Associate Professor Stephen Macfarlane, FRANZCP, Head of Clinical Governance, Dementia Centre HammondCare, who is conducting the study. “Of noticeable interest was also HAM-D data showing beneficial effects of ANAVEX 2-73 on insomnia, agitation and anxiety at 31 weeks, which might suggest an additional important role of ANAVEX 2-73 for the amelioration of behavioral and psychological symptoms of dementia (BPSD).”
The poster presentation is available on the publications page of the Anavex website.
“This clinical data together with prior preclinical findings seem to confirm ANAVEX 2-73’s selective activation of the specific stress reducing and survival protein, Sigma-1 receptor. This seems to present a potential common pathway for rescuing major neurodevelopmental and neurodegenerative disease mechanisms, like in Autism-related disorders and Alzheimer’s disease. I believe the distinct mechanistic nature suggests the compound could be a candidate treatment for a precision medicine approach across a spectrum of different neurological and psychiatric diseases,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory Board.
“By utilizing an adaptive design in our current ANAVEX 2-73 Phase 2a study, the treatment was finely adapted to the patient’s response, sparing patients from unnecessary side effects and safeguarding patients’ well-being, as evidenced by a high retention rate in this maximum tolerated dose (MTD) study,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are encouraged to proceed with the plan to confirm the data in a larger Phase 2/3 trial, for which planning is underway.”
About the ANAVEX 2-73 Phase 2a Study
The multi-center Phase 2a clinical trial of 32 mild-to-moderate Alzheimer’s patients consists of two parts. In PART A ANAVEX 2-73 is administered during five weeks in a randomized, open-label study with adaptive design. PART B is continued administration of ANAVEX 2-73 in a voluntary 52-week open-label extension, followed by an additional voluntary 104-week extension study, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over three years.
The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73. Secondary endpoints include 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), respectively.
Additional information regarding the ongoing Phase 2a clinical study is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
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, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. 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 and others. The Michael J. Fox Foundation (MJFF) 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.
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.
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