Combined Chances Prove Enduring Efficacy
Does Anavex 2-73 provide enduring, undiminished symptomatic stabilization or improvement for the entire period it’s administered (my claim); or, might the new drug lose potency for either a few or all who take it chronically? Will it stay strong throughout treatment, or lose effectiveness, as in the manner of Aricept? Why is my claim valid?
Thirty-two mid to moderate level Alzheimer’s patients participated in the Australian Phase1/Phase2 clinical trial. There were no reports of loss of efficacy over this 57-week period. All either remained at the initial symptomatic baseline, or cognition actually improved (no other cases of this of this magnitude and duration in any previous study).
Simply, there is not a shred of evidence that Anavex 2-73 loses potency. On the contrary, the evidence strongly supports the enduring efficacy thesis, that the drug works (or even improves symptoms) throughout chronic administration.
The claim that a much larger trial, testing much larger numbers of patients, is required to ascertain chronic efficacy is not supported by the Australian study. If this were a problem, even for only a portion of those on the drug, the plot of cerebral function would not have appeared in a rather straight, horizontal line, plotted against the 57-weeks of time. If the drug lost potency for some, the plot would have either declined (sloped downward toward the end), or the error bars would have widened at the end. Neither was the case.
The only chance that Anavex 2-73 might prove in a big Phase 3 trial to actually lose efficacy over a year would be that in larger populations, for some, this does occur, and that the Australian trial, merely by impossible chance, enrolled only people in which the drug did not lose efficacy. The chances of this are statistically miniscule. All in the Australian study retained efficacy, as will those in any larger study. The chances that only chronic efficacy responders were selected, and, by chance, any lose-efficacy non-responders were left out is tiny.
It’s not much of a factor, anyway. FDA does not require 100% patient efficacy for the approval of new drugs — just something better and safer than the current Standard of Care. Anavex 2-73 has those going away — as the big Phase 3 study will further affirm.
