Its lead candidate, Anavex 2-73 (A2-73 or blarcamesine) is currently in a Phase 2b/3 clinical trial on Alzheimer’s. A2-73 is an orally available drug candidate that targets Sigma-1 and muscarinic receptors (rather than existing amyloid plaques), with a clean safety profile that shows promise to halt and/or possibly even reverse the course of Alzheimer’s if taken early.
A2-73 has also completed a successful Phase 2 clinical trial for Parkinson’s dementia. In addition, A2-73 has shown strong Phase 3 results for the treatment of Rett Syndrome with data from a pediatric trial due in H2. The consistency of clinical trial success to date in all three diseases, and with strong statistical significance, is a very encouraging sign here.
Following a huge gain in 2021 (after a big gain in 2020), the shares have given back 27% year-to-date as investors ride out a quiet stretch awaiting trial results from the all-important 506-patient Phase 2b/3 Alzheimer’s trial as well as the 84-patient Rett adolescent trial, both due in the second half of this year.
In the meantime Anavex will be meeting with the FDA to okay its Phase 3 Parkinson’s trials on dementia and movement as well as to see if data from the 2 adult Rett trials completed so far could justify an approval for adult Rett syndrome even before the adolescent indication. Anavex has $150 million in cash to accomplish this.
Meanwhile, based on consistently positive and significant results across numerous clinical research trials (every one so far), the shares remain a "buy" for believers.