In an April 5 research note, DawsonJames Securities analyst Jason Kolbert reported that the Independent Data Safety Monitoring Board (DSMB) greenlighted Anavex Life Sciences Corp. (AVXL:NASDAQ) to continue, without changes, its Phase 2b/3 Alzheimer's disease study of ANAVEX2-73.
Kolbert pointed out that the biopharma's lead drug candidate ANAVEX2-73 activates the sigma-1 receptor (SIGMAR1). SIGMAR is believed to help remove misfolded proteins from neural cells and restore homeostasis, thereby helping the cells survive.
"The implications here could have an impact across a wide range of neurodegenerative diseases from Alzheimer's to Parkinson's and niche orphan diseases such as Rett's syndrome, which may represent a 'fast path' to establish proof of concept around the sigma 1 agonism," wrote Kolbert.
The analyst also noted that the Phase 2b/3 study "includes prespecified SIGMAR1 gene expression as endpoints using [the] Alzheimer's Disease Assessment Scale–cognition and [the] Alzheimer’s Disease Cooperative Study–activities of daily living as primary endpoints."
The company completed 92% enrollment of this 450-patient study. Topline data for the trial are expected in H1/22, as are topline data from two additional trials. They are AVATAR in Rett's syndrome and the Phase 1 ANAVEX3-71 in frontotemporal dementia.
As for additional 2021 catalysts, Anavex Life Sciences plans to initiate three additional clinical trials. They are the ANAVEX2-73 imaging-focused Parkinson's disease study, a Phase 2/3 Fragile X study and a Phase 2/3 study "for the treatment of a new, rare disease indication," he wrote.
DawsonJames has a Buy rating and a $19 per share target price on Anavex Life Sciences, the stock of which is now trading at about $15.38 per share.
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