Alzheimer's Continues to Baffle Drug Companies
The Alzheimer’s Association International Conference was held in Washington, D.C., a few weeks ago, and reports from the meeting were both encouraging and discouraging.
On the bad news side, the journal Science recently reported that 123 medicines intended to treat Alzheimer’s disease failed to make it through FDA trials between 1998–2014. In that time frame, only four drugs were approved: Razadyne, Namenda, Exelon and Namzaric. The latter is a combination of the only other Alzheimer’s drug previously approved — donepezil — and memantine.
None of the five drugs is anything close to a cure, much less a good universal treatment. In fact, they tend only to mask symptoms, according to the Alzheimer’s Association, and do not delay progression of the disease or treat the underlying cause.
Major and minor pharma companies have poured billions of dollars into Alzheimer’s drugs, with no victory in sight. Yet many more FDA trials are in the works.
At the conference, Eli Lilly’s new drug, solanezumab, was reported to have some functional benefits if started early in the disease. Two original Phase 3 studies of the drug had shown no significant benefits to people with advanced Alzheimer’s.
Lilly’s new Phase 3 trial for solanezumab is focusing on mild cases of Alzheimer’s, with hopes it will show delay of progression in the disease. This is a case of taking a generalized drug (for all Alzheimer’s patients) and focusing it on a specific variation of the disease for which it seems to have more efficacy (mild cases). The last patient in the new Phase 3 trial will be dosed in October 2016. Results may not be available until 2017.
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