First Patient Enrolled in Anavex Life Sciences Phase 2b/3 Clinical Trial of ANAVEX®2-73 for the Treatment of Early Alzheimer’s Disease
ANAVEX®2-73 Being Studied as Potential First Precision Medicine Biomarker-guided, Targeted Therapeutic in Alzheimer’s Disease
Primary and Secondary Endpoints measuring Safety, and Cognitive and Functional Efficacy (ADAS-Cog, ADCS-ADL and CDR-SB)
NEW YORK – August 28, 2018
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, Rett syndrome and other central nervous system (CNS) diseases, today announced that it has enrolled the first patient in its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study will enroll approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. As part of the planned international study, North American sites will be added.
“We are very excited to have now commenced the study, having enrolled our first patient. This highly-anticipated trial has generated great interest in Australia and overseas, and we now look forward to a phase of rapid recruitment of those who have registered their intent to participate,” commented A/Prof Stephen Macfarlane, FRANZCP, Head of Clinical Services for The Dementia Centre, HammondCare, and Principal Investigator of the Phase2b/3 study.
The ANAVEX®2-73 Phase 2b/3 study design incorporates genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study. Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).
“We are very pleased to initiate our first patient enrollment into the Phase 2b/3 study of ANAVEX®2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This is an important step toward achieving clinical data in regard to the treatment of early Alzheimer’ disease, which continues to represent an area of very high unmet need for the growing number of patients globally. Incorporating genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study is an incredibly important aspect of this study and we look forward to the insights gained through this data.”
About the ANAVEX®2-73 Alzheimer’s Disease Clinical Phase 2b/3 Study
For patients within Australia who wish to be considered for participation in this study, please visit the Ethics Committee (EC)-approved website, www.anavexaustralia.com. Patient candidates can register their interest in the study and answer a few simple screening questions. For those without internet access, expressions of interest can be registered by calling 02 8437 7355.
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 study, ANAVEX®2-73 has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Whole DNA Exome Sequencing (WES) and RNA expression genomic analysis of ANAVEX®2-73 Phase 2a Alzheimer’s disease patients was performed. The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study.
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. ANAVEX®2-73 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 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 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 neuroinflammation and mitochondrial dysfunction. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.
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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