Anavex (AVXL), is a biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system diseases with very encouraging results so far in Alzheimer’s, Parkinson’s and Rett Syndrome, suggests Tom Bishop, editor of BI Research.
The big news for Anavex was the release of the preliminary data from the 508 patient, placebo controlled, double-blind, 48-week, Phase 2b/3 ANAVEX 2-73 (blarcamesine or A2-73) Alzheimer’s trial which tested 3 equal cohorts with placebo, 30 mg or 50 mg oral doses.
First I need to point out two very important things:
1) There was a delay in getting the data from one of the trial sites that resulted in the company only getting the data from the third party statistical analysis company just 1 day before it was on the schedule to present at the CTAD Alzheimer’s conference. This therefore limited what the company could accurately report at that time.
2) Some of the best results from an earlier trial were for the 50 mg. cohort, while the 30 mg barely worked. However, ALL of the analysis presented recently was for the combined 30+50 mg patients as a single cohort, diluting the efficacy results.
Therefore, results yet to come should be even better once the company reports on the 50 mg cohort by itself. The primary endpoints were the reduction in the decline of cognition (ADAS-COG) and activities of daily living (ADCS-ADL) at 48 weeks.
On this the company said, “The Anavex 2-73 (blarcamesine) study met the primary and key secondary endpoints showing statistically significant reduction of clinical decline in global cognitive and functional scales in a clinical study of patients with early Alzheimer’s disease.” (MMSE baseline scores 20-28).
And more to the point: “Treatment with ANAVEX®2-73 statistically significantly reduced cognitive decline, measured with ADAS-Cog, compared to placebo at end of treatment by 45% (p=0.033).”
This is the most significant and directly on point outcome released so far for this trial given this was considerably better than Biogen/Eisai’s 27% slowing of cognitive decline recently reported for lecanemab.
Nonetheless lecanemab's meager result caused those two companies to increase $20 billion in market cap overnight. Most observers believe this Phase 3 result paves the way for likely FDA approval. However, Anavex’s drug beat lecanemab by a wide margin (a 45% slowing vs. 27%) in its Phase2b/3 trial.
But here’s the thing … Biogen’s drug requires IV infusion therapy and periodic MRIs to check for brain swelling and bleeding (two nasty side effects of lecanemab), while A2-73 is a pill and doesn’t require periodic MRI’s, a huge advantage even ignoring that A2-73 worked better.
While the data already released was superior to lecanemab, once the 50 mg alone cohort data comes out the results should be considerably better than for the combined group. So I think the data so far was encouraging, but the best news is yet to come — and the stock remains a favorite for 2023.