Elan and Wyeth Report Encouraging Results From Phase II Alzheimer’s Trial
Elan and Wyeth have announced positive preliminary findings from a Phase II study of bapineuzumab in patients with mild to moderate Alzheimer’s disease.
In the 18-month trial, bapineuzumab appeared to have clinical activity in treating Alzheimer’s disease. The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. However, post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups.
In non-carriers of the Apolipoprotein E4 (ApoE4) allele, estimated in the literature to be from 40 to 70% of the Alzheimer’s disease population, post-hoc analyses showed statistically significant and clinically meaningful benefits associated with bapineuzumab treatment on several key efficacy endpoints, including the Alzheimer’s disease assessment scale (ADAS-cog), the neuropsychological test battery (NTB), the mini mental state examination (MMSE) and the clinical dementia rating – sum of boxes (CDR-SB). A favorable directional change was seen on the disability assessment scale for dementia (DAD), although this was not statistically significant.
Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant.
In similar post-hoc analyses of carriers of the ApoE4 allele, no clinical benefits or statistically significant effects were observed on efficacy endpoints or the brain volume endpoint. However, favorable directional changes were observed on a number of endpoints.
Kelly Martin, president and CEO of Elan, said: “The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer’s disease and an important milestone in our companies’s ongoing commitment to bring new treatment options to patients.”