Anavex Life Sciences Provides Update on Clinical Program Development as Response to COVID-19
NEW YORK – March 31, 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 provided an update on the evolving COVID-19 condition and the Company’s response to its clinical program development.
Anavex’s paramount obligation is to ensure the safety of all participants in its clinical programs and the integrity of the studies in which they participate. Anavex is responding to regulatory, institutional, and government guidance and policies related to COVID-19. Anavex remains committed to its clinical development plans and is working closely with all stakeholders to try to mitigate the effect of COVID-19 on the Company’s ongoing clinical trials for Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease.
Clinical sites continue to operate and see patients where possible in accordance with local regulations and site policies, regulatory, institutional, and government guidance related to COVID-19. Clinical sites continue to screen and enroll patients into the active trials and the respective open-label extensions for the two Phase 2 Rett syndrome trials and the Phase 2b/3 Alzheimer’s disease trial, while the Parkinson’s disease dementia Phase 2 trial has completed enrollment and we expect to announce topline results from this study by mid-2020.
Anavex pro-actively continues to bring on sites in new countries across programs depending on the situation in each country of operations. While Rett syndrome protocols ANAVEX2-73-RS-001 and ANAVEX2-73-RS-002 have always by default allowed at-home visits, U.S. FDA and European EMA and Australian TGA recommended contingency plans are actively in place for the Alzheimer’s disease Phase 2b/3 study ANAVEX2-73-AD-004 and the Parkinson’s disease dementia Phase 2 study ANAVEX2-73-PDD-001 to ensure remote or virtual assessments for active patients and all respective extension studies.
Because ANAVEX2-73 is an oral formulation, study participants are able to receive shipments of their study medication in a controlled and compliant fashion, and direct-to-patient delivery is occurring in multiple countries.
“We understand that some activities will be temporarily slower because of COVID-19, however, our risk-mitigation actions were implemented for every project and Anavex’s primary focus is on the safety of all involved and the continued conduct of our clinical programs as we navigate the pandemic together”, said Christopher U Missling, PhD. “Our sites understand why their patients participate in research and are committed to the importance of clinical trials for those patient communities currently without effective treatments.”
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 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 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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