Anavex Life Sciences Corp (AVXL)

[Steady_T]

Here is a paragraph from the Anavex PR on the 3-71 P1 study.

ANAVEX®3-71 was well tolerated in all cohorts receiving ANAVEX®3-71 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. In the study, ANAVEX®3-71 exhibited linear pharmacokinetics. Its pharmacokinetics was also dose proportional for doses up to 160 mg. Gender had no effect on the PK of the drug and food had no effect on the bioavailability of ANAVEX®3-71. The study also met the secondary objective of characterizing the effect of ANAVEX®3-71 on electrocardiogram (ECG) parameters. There were no clinically significant ECG parameters throughout the study. Participant QTcF measures were normal across all dose groups with no difference between ANAVEX®3-71 and Placebo.

The rat study used 10ug/kg dosing. That shows that very small amounts of 3-71 have an effect, at least in rats. It does not indicate the maximum effective dose.

The P2 study should show what the max effective dose is for schizophrenia. However, it could be even more than the 60mg target dose in the P2 trial or they may find that there is a ceiling effect and a dose larger than 30mg is no more effective.