AD02: Phase II data
Affiris' AD02 performed worse than placebo in a double-blind, international Phase II trial in 332 patients with early stage AD. Specifically, Affiris said AD02 missed the primary endpoint of improving composite ADAS-Cog and ADCS-ADL score vs. placebo vaccine, but that the placebo vaccine showed significant results on the primary endpoint. The company now plans to focus on further clinical development of the placebo vaccine - now called AD04 - but did not disclose details regarding the mechanism of action or next steps. Affiris said that 24-31% of patients who received AD02 showed stabilization of their cognitive and functional status for >=18 months vs. 47% of patients who received AD04. The company also said there was significant correlation between stable disease and prevention of decline in hippocampus volume in patients treated with AD04 (p=0.0016) that was not observed in patients treated with AD02. ...