Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE) announced encouraging preliminary findings from a Phase 2 study of bapineuzumab (AAB-001) 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. 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 percent 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. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. Progression of Alzheimer’s disease is generally associated with loss in brain volume and increases in ventricular volume. Further, treatment-related benefits seen on MRI were correlated to the favorable clinical changes observed in non-carriers.
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. Preliminary analyses suggest possible increase of ventricular volume in treated patients versus placebo patients. The clinical significance of this finding is currently unclear and analyses are ongoing.
“The preliminary analyses of the Phase 2 study are a continued validation of the amyloid approach to Alzheimer’s disease and an important milestone in our companies’ ongoing commitment to bring new treatment options to patients,” said Kelly Martin, President and CEO of Elan. “These results clinically support our decision to move into Phase 3 last year.”
“We are encouraged by these findings. We remain driven by science and focused on patients as we work to bring this treatment to those who desperately need new options,” said Bernard Poussot, President and CEO, Wyeth. “We recognize there is a great deal of hard work left as we move from this phase of learning towards confirming the potential of bapineuzumab.”
Source: Wyeth, USA