Elan keeps faith in Alzheimer drug
Elan Corporation plans to advance ELND005 into phase III testing, despite data indicating that it missed the co-primary endpoints in a phase II AD201 trial for Alzheimer's. According to the trial results, ELND005, a small molecule that disaggregates beta amyloid fibrils, failed to significantly improve cognitive and functional measures for up to 18 months. However, the Irish biotech company and its partner Transition Therapeutics have said that the drug appeared safe, and had a biological effect on the amyloid-beta protein in the cerebrospinal fluid. Analysts think that the two companies will be looking for a further partner to share risk before embarking on a costly phase III study. Elan also recently opted to put off a sale or spin-off for its drug delivery unit.
The final analysis of the finished phase II trial excluded all 180 patients from the 1,000 and 2,000 mg high-dose groups. The partners discontinued these groups last year following an analysis by an independent safety monitoring committee that showing a higher rate of serious adverse events in the cohorts, including nine deaths. Rates of serious adverse events for 250 mg ELND005 and placebo were 21.6% and 13.3%, respectively, while rates of serious adverse events thought to be treatment-related were 2.3% and 2.4%, respectively.