Anavex Life Sciences Corp (AVXL)

[rocalinda]

Good, clear, informative article. One thing, however: seems to conflictive information in the article about start of Ph 2/3 trial. Is it before the end of the year or after extension in 2018?

— Kenneth Dreesen (@Dreesenkl) November 21, 2017

Dr. Missling said ANAVEX 2-73 still appears safe and well tolerated. In the initial study phase, 98% of the subjects did have an adverse event; only one was considered serious. This was a case of delirium that developed in a patient who had several risk factors for the disorder, including a prior episode, and was not considered related to the study drug. Three patients withdrew because of an adverse event in the first 57 weeks; no one has withdrawn because of a side effect since then.

Dizziness was the most common adverse event (20 incidents in 15 patients), followed by headache (16 in 10 patients). Most (94%) occurred in the first week of treatment. All were mild or moderate. Headache and dizziness are considered signs that patients are approaching their maximum tolerated dose, Dr. Missling said.

“We’re trying to gather as much data as possible so we can do this properly,” Dr. Missling said. “You can make the case that some developers have rushed into these studies after interpreting early results the wrong way. They said the glass was half-full when it was really half-empty. For us, it’s very important not to do that. We won’t go ahead with this until we are completely comfortable with what we see.”