Solanezumab Phase 3 Clinical Trial Results Bring New and Encouraging Information
http://www.businessweek.com/ap/2012-08-24/lilly-alzheimers-drug-trial-yields-promising-sign
Eli Lilly and Company announced today that two Phase 3 studies of an experimental drug therapy called solanezumab in mild to moderate Alzheimer’s disease did not meet their primary endpoints.
However, there is new and encouraging information in the trial results. According to the company, in a secondary pooled analysis of both studies, the drug at the tested dose showed a statistically significant slowing of cognitive decline in people with mild to moderate Alzheimer’s disease; the results were driven by people with mild Alzheimer’s. If this finding can be duplicated, it suggests that an Alzheimer’s therapy targeting beta amyloid can have a beneficial effect on cognitive abilities in people with mild to moderate Alzheimer’s. That would be a major step forward in the fight against Alzheimer’s disease.
Another hopeful sign is that, according to the company, an open label extension study of this drug will continue. This means that people who were in the Phase 3 trials will have an opportunity to continue taking the drug. This will give us further insight into the effects of this drug over a longer period of time, and also into the value of amyloid-based therapies for people with Alzheimer’s.
The company has only reported “topline” results at this time. More details will be available at the American Neurological Association annual meeting in early October. The company also says that “next steps for solanezumab have not yet been decided and will be determined after discussions with regulators.” The Alzheimer’s Association looks forward to seeing the full data from these studies, and also hearing about the company’s discussions with the FDA about next steps for this drug.