Summary of when readouts are expected for AD, PD and Rett (Excellence study) from Seeking Alpha article: Anavex Life Sciences: Upcoming Readouts In Alzheimer's And Parkinson's Disease Dementia
Sep. 19, 2022 5:59 PM ET
"During the call on results for the third quarter of 2022, Anavex mentioned that it is completing finalizing activities to report top-line results of the placebo-controlled Phase 2b/3 study of Anavex 2-73 in early Alzheimer’s disease, expected this coming fall. Data from the 48-week open-label extension of the Parkinson disease dementia Phase 2 study is expected by year-end 2022. Also by year end 2022, Anavex will be reporting on the randomized placebo-controlled Excellence Phase 2/3 study for the treatment of pediatric patients with Rett syndrome."
It is debatable whether Anavex will timely meet its schedule for reporting as stated above, and some here believe that the Excellence data, for example, may not be reported until sometime after the end of this year. However, I agree with frrol that AD and PDD should be reported soon. Hopefully, these reports will be straight forward and not controversial as the past PDD "Proof of Concept" trial.
I believe we will receive the AD readout first. The above article states: "Primary endpoints of interest are Adas-Cog to assess cognition and ADCS-ADL for daily function. Key secondary endpoints are, among others, CDR-SB or Clinical Dementia Rating Sum of Boxes, structural and functional MRI, and both blood and cerebral spinal fluid biomarkers of Abeta40, Abeta42, T-tau, NFL, YKL-40, BACE1 and neurogranin. The most important results for investors will of course come from the primary endpoints Adas-Cog and ADCS-ADL and secondary endpoint CDR-SB.".
The article further states: "To be clear, Anavex has not yet reported Adas-Cog results either in Alzheimer’s or in Parkinson’s Disease Dementia...... Anavex has on several occasions calculated what the results in Adas-Cog would be in light of already existing reporting. It has done so for Alzheimer’s results at week 57, but not at week 148. For the Alzheimer’s patients at week 57, it had mentioned a calculated Adas-Cog score of -3.4 that correlated to a +2.0 points improvement on MMSE at week 57. Of note: the 2016 reporting mentioned a +1.8 point improvement for the total patient group. In Parkinson’s Disease Dementia patients, Anavex has reported calculated Adas-Cog results at week 14."
So, it will be interesting and most important, I think, to see the actual Adas-Cog results from the AD imminent report. However, I am not clear about the actual dosing for this AD trial and the number of patients on each dose. The dosing regimen, I think, is simply labeled as Drug: High dose ANAVEX2-73, Drug: Mid dose ANAVEX2-73, and Drug: Placebo oral capsule. So, how will the results be reported per dosing regimen? Will we receive Adas-Cog scores per high dose and low dose? How many patients are on the high dose, and how many on the low dose? Will the results be controversial regarding the number of patients on each dose and the improvement of patients per dose? If only the high dose patients (by way of only one example) show significant cog improvement, will the number of patients on the high dose be sufficient and meaningful for a clinical trial?
