Rett Syndrome Association of Australia and Anavex Life Sciences Announce Initiation of the Phase 2 AVATAR Clinical Study in Patients with Rett Syndrome
MELBOURNE and NEW YORK – May 8, 2019 – Rett Syndrome Association of Australia and 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, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the approval by the Australian Human Research Ethics Committee to initiate an approximately 30 patient Phase 2 double-blind, randomized, placebo-controlled, study of ANAVEX®2-73 for the treatment of Rett syndrome, called AVATAR (ANAVEX®2-73 assessment of safety and efficacy in Rett syndrome patients). The AVATAR study is scheduled to initiate this quarter.
The Phase 2 study will use a convenient once-daily oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. Safety and efficacy will be investigated in approximately 30 patients over a 7-week treatment period including ANAVEX®2-73-specific precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study is part of a planned Anavex Rett syndrome program including further studies of ANAVEX®2-73 in wider age range and other geographic regions.
About the AVATAR Rett Syndrome Clinical Phase 2 Study
For patients who wish to learn more about this study, please visit the website, www.rettsyndrometrial.com.
RSAA will also make the necessary bookings and pay for them directly so as not to burden and leave participants and their families out of pocket for major expenses whilst directly participating in the AVATAR trial. Please contact Claude Buda, RSAA President, directly by phone or email for any inquiries:
Claude Buda, RSAA President
Phone: +61 (0)411 089 156
Previously, administration of ANAVEX®2-73 resulted in both significant and dose related improvements in an array of behavioral paradigms in two MECP2 HET Rett syndrome disease models. These behavioral paradigms measured different aspects of muscular coordination, balance, motor learning and muscular strengths, some of the core deficits observed in Rett syndrome. Anavex is utilizing innovative strategies in trial design in order to effectively and efficiently translate preclinical and clinical findings into an exploration of ANAVEX®2-73 as a potential therapeutic in Rett syndrome.
“Rett syndrome, which is seen almost exclusively in females, is a genetic disorder in which the brain does not mature in the way it should. For most affected children, their early development appears normal but then slows down or suddenly halts, said Claude Buda, President of RSAA. “There are currently no approved therapies for Rett syndrome and we welcome the opportunity to explore a disease-modifying treatment option to Australian families.”
“We are proud to have partnered with the Rett Syndrome Association of Australia in the design of the AVATAR study and thrilled that we have taken an important step in advancing the development of a potential treatment for Rett syndrome that may benefit the families and individuals living with this disorder,” said Christopher U Missling, PhD, Chief Executive Officer of Anavex. Walter E Kaufmann, MD, Chief Medical Officer of Anavex commented, “ANAVEX®2-73 highlights our commitment to developing transformative therapies for people and their families living with Rett syndrome.”
About Rett Syndrome Association of Australia (RSAA)
Formed in Melbourne in July 1989, the Rett Syndrome Association of Australia Inc. (RSAA) is a not-for-profit organisation which is managed by a Committee of volunteers, most of whom are parents of Rett syndrome children. July 2019 will mark RSAA’s 30th anniversary. The Association seeks to improve the quality of life for persons with the syndrome and their families and be of assistance to anyone interested in the disorder.
Please click www.rettaustralia.org.au to read more about RSAA.
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, Parkinson’s disease, Rett syndrome and 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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