By "mediocre" data are you referring to efficacy, a secondary endpoint of the trial btw? I'm gonna assume you were. Why did you expect cure or stabilization at 31 weeks when doses aren't optimized and donepezil has a counteracting affect on 2-73? Actually, the seven 273 montherapy patients showed stable mmse and adcs adl, in fact the mmse went up 3+ points at 31 weeks. The Part A of Phase 2A involved on-off dosing with differing dosages and 12 days off 273. Keep your expectations realistic. Only traders of AVXL found the 31 week results mediocre or poor. Scientists, Anavex, Biogen, and FDA found results promising given the trial's exploratory design.
Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, commented: “To interpret the ANAVEX 2-73 results presented at the 2016 AAIC meeting, it is important to keep in mind the stated goals of this first in Alzheimer’s patients study. This was a Phase 2a study, primarily designed to determine which ANAVEX 2-73 dosages are safe to administer to mild to moderate stage Alzheimer’s patients. The study was successful in establishing the maximum tolerated dose and in revealing the range of ANAVEX 2-73 doses that are well-tolerated by Alzheimer patients. It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. However, this analysis was based on pooled data from a relatively small number of subjects receiving a variety of doses. It is therefore unlikely that these findings reflect the full potential ANAVEX 2-73 in treating Alzheimer’s disease. It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”
