Compassionate Use Special Access Scheme Approval for Alzheimer’s Patients to Continue Treatment with ANAVEX®2-73 (blarcamesine) after Completing the 5-Year ANAVEX®2-73-003 Phase 2a Clinical Study
NEW YORK – August 5, 2020
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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that patients from the ANAVEX®2-73-003 phase 2a Alzheimer’s disease trial will continue treatment with ANAVEX®2-73 (blarcamesine) via the Australian Government Department of Health – Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme following completion of over 5-years daily dosing of ANAVEX®2-73 (blarcamesine) and recommendation by their physicians.
The TGA approved the Special Access Scheme Category B applications based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that ANAVEX®2-73 (blarcamesine) may benefit patients. Anavex will facilitate continued access to ANAVEX®2-73 (blarcamesine) through the Special Access Scheme at the physicians’ request.
“We are honored to support medical professionals and their patients seeking treatment for Alzheimer’s disease and who have very few medical options,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical ANAVEX®2-73-002/-003 studies are exploring the long-term effect of daily treatment with ANAVEX®2-73 (blarcamesine) over 5 years, however it is pleasing that physicians have requested extended treatment of their patients with ANAVEX®2-73 (blarcamesine) beyond these 5 years.”
The Special Access Scheme:
Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies.
About ANAVEX®2-73 (blarcamesine)
ANAVEX®2-73 (blarcamesine) 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 the Phase 2a 57-week Alzheimer’s disease (AD) ANAVEX®2-73-002 (ClinicalTrials.gov NCT02244541) study, ANAVEX®2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Its open-label extension study ANAVEX®2-73-003 (ClinicalTrials.gov NCT02756858) for an additional 208 weeks included full genomic analysis of patients with Alzheimer’s disease treated with ANAVEX®2-73 (blarcamesine). A 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX®2-73 (blarcamesine) in 450 patients with early Alzheimer’s disease is ongoing and currently over 60% enrolled.
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 disorders 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 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising clinical 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 mitochondrial dysfunction and neuroinflammation. 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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