Anavex Life Sciences Corp (AVXL)

[JB3729]

PART B runs for 52 weeks. The 5 week PART A is not included in PART B.

The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients enrolled 32 participants. It commenced in January 2015 and the participants, the majority of whom are also taking donepezil, have now completed PART A of the two-part trial. Lasting up to 36 days (5 weeks) for each patient, PART A was a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (ERP) were used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for a further 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers. PART B utilizes daily oral dosing in order to establish a longer drug effect.