Anavex Life Sciences Announces 12-Month Data of ANAVEX 2-73 in a Phase 2a Study in Mild-to-Moderate Alzheimer’s Disease Patients
Data presentation at CTAD 2016
New York, NY – December 8, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today announced a positive 57-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. The study met both primary and secondary endpoints.
At 57 weeks, Alzheimer’s patients taking a daily oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events.
Published AD studies confirmed substantial declines of cognitive (MMSE) and functional (ADCS-ADL) measures as well as Cogstate and EEG/ERP over 12 month in similar AD populations. Pre-specified exploratory analyses of the current study included the cognitive (MMSE) and the functional (ADCS-ADL) as well as Cogstate, HAM-D and EEG/ERP changes from baseline.
Specifically, in comparison to historical control from a pooled placebo arm cohort study conducted by the Alzheimer Disease Cooperative Study Group in mild-to-moderate AD patients of comparable ages and MMSE baselines, over 12 month the ANAVEX 2-73 data shows a calculated treatment benefit of 1.8 points on the MMSE scale (p<0.016) and a calculated treatment benefit of 4 points on the ADCS-ADL score (p<0.019). Furthermore, the correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, commented, “In addition to the very encouraging results, which point to the therapeutic potential of targeting cellular homeostasis in a complex CNS disease like Alzheimer’s, this trial has been intelligently designed as a highly informative study, looking unprejudiced at all potential relationships and hence allowing to learn from all correlations of the now available pool of data, in order to execute subsequent trials with much more relevant information at hand.”
Despite non-optimized dosing of ANAVEX 2-73 throughout the 12-month study, continued significant improvements from baseline of cognitive, functional and behavioral scores in a group of patients were observed, respectively. This data will be analyzed using refined mathematical modeling methods in conjunction with the detailed pharmacokinetic (PK) information.
“Alzheimer’s disease is a progressive neurodegenerative disease that causes problems with memory, thinking and behavior. Currently available treatments cannot stop Alzheimer's from progressing; they can only temporarily slow the worsening of dementia symptoms,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We believe this data gives us a solid foundation from which to continue the next phase of rationally designed clinical trials. Anavex is grateful for the dedication of the patients, their families and the clinical investigators who participated in this study."
The Company is presenting findings from the study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on Saturday, December 10th at 8:45 a.m. PT in the oral communication session. The presentation will be available in the publications section of the Anavex website.
The company will also conduct a conference call with the investment community in conjunction with the upcoming financial year-end 2016 report.
About the ANAVEX 2-73 Phase 2a Study
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is 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 is 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 is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints include 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 EEG/ERP.
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About CTAD 2016
The International Conference on Clinical Trials for Alzheimer’s Disease (CTAD) is an annual conference organized and planned by Alzheimer’s disease clinical researchers to share scientific information with each other. The 9th annual CTAD 2016 will be held December 8-10 in San Diego, CA. Further information is available at http://www.ctad-alzheimer.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, is currently in 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 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. 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.
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 Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matt Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
Data presentation at CTAD 2016
New York, NY – December 8, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today announced a positive 57-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. The study met both primary and secondary endpoints.
At 57 weeks, Alzheimer’s patients taking a daily oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events.
Published AD studies confirmed substantial declines of cognitive (MMSE) and functional (ADCS-ADL) measures as well as Cogstate and EEG/ERP over 12 month in similar AD populations. Pre-specified exploratory analyses of the current study included the cognitive (MMSE) and the functional (ADCS-ADL) as well as Cogstate, HAM-D and EEG/ERP changes from baseline.
Specifically, in comparison to historical control from a pooled placebo arm cohort study conducted by the Alzheimer Disease Cooperative Study Group in mild-to-moderate AD patients of comparable ages and MMSE baselines, over 12 month the ANAVEX 2-73 data shows a calculated treatment benefit of 1.8 points on the MMSE scale (p<0.016) and a calculated treatment benefit of 4 points on the ADCS-ADL score (p<0.019). Furthermore, the correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).
George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, commented, “In addition to the very encouraging results, which point to the therapeutic potential of targeting cellular homeostasis in a complex CNS disease like Alzheimer’s, this trial has been intelligently designed as a highly informative study, looking unprejudiced at all potential relationships and hence allowing to learn from all correlations of the now available pool of data, in order to execute subsequent trials with much more relevant information at hand.”
Despite non-optimized dosing of ANAVEX 2-73 throughout the 12-month study, continued significant improvements from baseline of cognitive, functional and behavioral scores in a group of patients were observed, respectively. This data will be analyzed using refined mathematical modeling methods in conjunction with the detailed pharmacokinetic (PK) information.
“Alzheimer’s disease is a progressive neurodegenerative disease that causes problems with memory, thinking and behavior. Currently available treatments cannot stop Alzheimer's from progressing; they can only temporarily slow the worsening of dementia symptoms,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We believe this data gives us a solid foundation from which to continue the next phase of rationally designed clinical trials. Anavex is grateful for the dedication of the patients, their families and the clinical investigators who participated in this study."
The Company is presenting findings from the study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on Saturday, December 10th at 8:45 a.m. PT in the oral communication session. The presentation will be available in the publications section of the Anavex website.
The company will also conduct a conference call with the investment community in conjunction with the upcoming financial year-end 2016 report.
About the ANAVEX 2-73 Phase 2a Study
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is 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 is 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 is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints include 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 EEG/ERP.
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About CTAD 2016
The International Conference on Clinical Trials for Alzheimer’s Disease (CTAD) is an annual conference organized and planned by Alzheimer’s disease clinical researchers to share scientific information with each other. The 9th annual CTAD 2016 will be held December 8-10 in San Diego, CA. Further information is available at http://www.ctad-alzheimer.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, is currently in 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 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. 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.
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 Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matt Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
