The Australian GDH (Government Department of Health) – TGA (Therapeutic Goods Administration) granted SAS (Special Access Scheme) approval Anavex2-73 of Anavex Life Sciences Corp (NASDAQ:AVXL) to treat patients who have Alzheimer’s disease.
Receives CTA from MHRA
MHRA (Medicines and Healthcare products Regulatory Agency) granted CTA (Clinical Trial Authorization) in the UK to Anavex in June 2020. Health Canada issued NOL (No objection letter) to Anavex for expanding the presence of global Phase 2b/ 3 randomized, double-blind, and placebo-controlled efficacy and safety trial of Anavex2-73 to cure patients with early Alzheimer’s disease to Canada and the UK.
Exceeds enrollment target for Phase 2 clinical study
Anavex recruited more than 50% of candidates for Phase 2 Clinical study of Anavex2-73 in Rett Syndrome in the US in June 2020. It will publish topline results of this study in Q4 2020.
The first dose is given to the pediatric patient in July 2020 for the Phase 2/ 3 clinical trial of ANAVEX®2-73 to cure Rett syndrome with blarcamesine.
Enrolls the first patient in Anavex 3-71 Phase 1 clinical trial
Anavex recruited the first patient for AF701B (Anavex 3-71) Phase 1 clinical study in July 2020. The orally administered molecule that targets M1 muscarinic and Sigma-1 receptors is developed to treat neurodegenerative diseases. It will announce the topline data of this clinical trial in H1 2021.
Anavex holds CE (Cash equivalents) and Cash of $27.6 million by the end of June 30, 2020. Its expenses on R&D in Q3 2020 increased marginally to $6.7 million. The company posted a $6.5 million net loss in this quarter.
Shake It Up Foundation will invest in Anavex
Shake It Up Foundation will pay for up to 50% of Anavex’s spending on a disease-modifying clinical trial to develop blarcamesine to cure Parkinson’s disease. Founder of Shake It Up, Clyde Campbell said the organization is excited to support the development of innovative drugs to cure patients with Parkinson’s disease and the like.
CEO of Anavex, Christopher Missling, said the collaboration with Shake It Up helps the company to Anavex2-73 development and investigate the drug a potential disease-modifying agent to cure Parkinson’s disease. He said Shake It Up is committed to supporting developing drugs for unmet medical needs.