Anavex Life Sciences Corp (AVXL)

[Doc328]

“This is the first gut microbiota DNA sequencing analysis of Alzheimer’s disease patients treated with ANAVEX®2-73, which might help to identify potential biomarkers of response for ANAVEX®2-73,” said Christopher U. Missling. Which might help to identify potential biomarkers. Two qualifiers within 5 words! Can you get more non-committal?

I have several concerns. First the data is mixed at best. According to slide 15 which is the meat of the presentation, those patients who did better on the ADCS-ADL had higher levels of two families, Ruminococcaceae and Porphyromonadaceae. However, the significance of this is unclear. The Vogt paper finds (figure 1d) that control gut has lower levels of bacteroidetes than AD gut. Porphyromonadaceae is a bacteroidetes so wouldn’t a lower levels in ‘responders’ be expected. Furthermore, the intent of a treatment biomarker is to give you an objective measure more accurate or more responsive than the test measure (i.e ADAS-Cog or ADCS-ADL). Looking at the overlapping dots, in slide 15, an individual value has no meaning as the clusters overlap so much. Additionally, why are there only 14 dots when they tested 16 patients? My guess is that 2 of the 16 patients who gave a stool sample at 70-100 weeks dropped out by 148 weeks. Just how many people were left at 148 weeks? Why won’t Missling ever show the 148 week n values? Are people dropping out because of futility, side effects, death? Finally, why is there no data on MMSE correlations. Most likely because there were none. The ADCS-ADL is a caregiver measure not a patient measure and IMO not very valuable in an open label setting as the caregiver might see what they want to see. Did the spouse spike the stool, too? Also, since they only tested after +/- 18 months of A273 and there is no baseline data, we don't know whether the differences in the gut were present at study entry or as a result of A273.

As usual, AVXL presents at a meeting and the data raises more questions than are answered. It’s no wonder the price dropped after people had a chance to think about the talk.