Exactly a year ago today, Anavex Life Sciences Corp. (AVXL) was trading around $3 when we had featured it in our Stock To Watch column. Today, the stock touched a high of $28.68 in early trading and is currently at $18.
Anavex is a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders. The lead candidate is ANAVEX2-73, which is designed to work by restoring cellular homeostasis by targeting sigma-1 and muscarinic receptors. (Any process involved in the maintenance of an internal steady state at the level of the cell is known as cellular homeostasis. Source: Mouse Genome Informatics).
ANAVEX2-73 is being explored as a potential treatment for Alzheimer’s, Rett syndrome, Parkinson’s disease dementia, Infantile Spasms, Fragile X syndrome, and Angelman’s disease.
Clinical programs & Near-term Catalysts:
— A phase II/III clinical trial with ANAVEX2-73 for the treatment of pediatric Rett syndrome patients, dubbed EXCELLENCE, is ongoing.
— A U.S. phase II study of ANAVEX2-73 for the treatment of Rett syndrome in adults, for which positive top-line results were reported last December. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway.
— A phase II study of ANAVEX2-73 in adult Rett syndrome, dubbed AVATAR, is underway. The top line data from this trial is expected in the first half of this year.
What is Rett syndrome?
Rett syndrome is a rare, non-inherited genetic post-natal progressive neurodevelopmental disorder that occurs almost exclusively in girls. The hallmark of this disorder is near constant repetitive hand movements while awake.
Currently, there are no approved treatments for Rett syndrome and antiepileptic drugs are used to control the symptoms.
— A proof of concept phase II trial of ANAVEX2-73 in patients with Parkinson’s disease dementia – for which positive results were reported last October.
— A phase IIb/III trial of ANAVEX2-73 for the treatment of early Alzheimer’s is ongoing, with complete enrollment expected in early 2021. The study is scheduled for completion next year.
What are the other programs in the pipeline apart from ANAVEX2-73?
— Anavex’s second novel clinical sigma-1 and muscarinic receptor program is ANAVEX3-71, which is being initially developed for the treatment of Frontotemporal Dementia.
A phase I trial evaluating the safety, tolerability, and pharmacokinetics (PK) of ANAVEX3-71 and the effects of food and gender on its PK in healthy volunteers was initiated last May. Topline data from this study is expected in the first half of this year.
What is Frontotemporal dementia?
Frontotemporal dementia (FTD) refers to a group of disorders caused by progressive nerve cell loss in the brain’s frontal lobes (the areas behind the forehead) or its temporal lobes (the regions behind the ears). (Source: Alzheimer’s Association).
— ANAVEX1-41, a mixed sigma-1, muscarinic and sodium-channel candidate drug, which is being explored in the indications of depression, stroke, Parkinson’s and Alzheimer’s, under preclinical testing.
— ANAVEX1066, a mixed Sigma-1/Sigma-2 receptor ligand, being developed for the treatment of neuropathic and visceral pain, under preclinical testing.
The company had cash and cash equivalents of $47.6 million as of December 28, 2020.
AVXL has traded in a range of $2.20 to $28.68 in the last 1 year. The stock is currently up 76% at $18.27.
Stock To Watch dated Feb.4, 2020
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