NEW YORK, NY / CRWEPRESSRELEASE / January 11, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported a positive dose-response relationship has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer’s disease.
The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.
The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects, with no adverse events reported above grade one.
“While we remain cautious about interpreting the results of an interim analysis, evidence of ANAVEX 2-73’s positive dose response at 5 weeks on the MMSE is a welcome signal”, said Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex. “Evidence of a dose-response relationship is one of the factors taken into account by regulatory agencies when ultimately considering medications for approval.”
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex stated, “Our team is encouraged by these findings and we look forward to advancing ANAVEX 2-73 into a larger Phase 2/3 study for Alzheimer’s as well as initiating a double-blinded, randomized, placebo-controlled Phase 2 trial for ANAVEX 2-73 in an additional indication associated with cognitive impairment.”
Detailed information on the results will be provided in an upcoming scientific meeting.
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 evaluation of safety and tolerability of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints were dose response, bioavailability, and exploratory cognitive effects using electroencephalographic (EEG) activity and event-related potentials (ERP), Cogstate battery, Mini Mental State Examination (MMSE), and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADSC-ADL) as well as the exploration of ANAVEX 2-73 as a potential add-on therapy to donepezil, the current standard of care.
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 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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data 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 convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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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