Biogen has success with early Alzheimers study for BIIB 037 and moves to Phase III

Biogen has announced top-line data from a pre-specified interim analysis of a phase 1b study of its anti-amyloid beta (Ab) antibody, BIIB 037, in prodromal and mild Alzheimer�s Disease (AD) at an investor event in Boston. BIIB reported that BIIB 037 reduced Ab levels in the brain in a dose- and time-dependent manner, and also demonstrated a statistically significant effect on cognition at week 54. "Overall, data are better than expected, with statistically significant improvement in cognition not anticipated in such a smaller study. Internal consistency of data, including dose and time dependence of Ab clearing as well as FDG-PET improvement in synaptic function in the brain, lend further support for a meaningful biologic and clinical effect that should be reproduced in phase 3," according to analysts .

The primary endpoint for the dose-escalation study was safety, but the trial also explored several secondary endpoints related to efficacy. Biogen is moving into Phase III based on the interim Phase Ib results

Detailed results will be presented at a medical meeting in 2015, potentially during the 12th International Conference on Alzheimer's & Parkinson's Diseases (AD/PD) from 18 to 22 March in Nice, France.