Lilly revisits Alzheimer’s drug
pharmafile | July 15, 2013 | News story | Research and Development, Sales and Marketing | Alzheimer's, lilly, solanezumab
Eli Lilly & Co is to run yet another trial of its Alzheimer’s drug solanezumab, which failed twice in Phase III trials last year in patients with mild to moderate Alzheimer’s.
Reuters reports that the US manufacturer plans to focus this time on patients with a mild form of the degenerative brain condition who appeared to respond to the treatment.
Lilly’s new Phase III trial will take in 2,100 patients – a big increase on the 1,300 with mild Alzheimer’s in the two previous studies.
There was nothing particularly surprising about the original failure: Alzheimer’s is a field littered with disappointment – Pfizer and Janssen’s investigational bapineuzumab was shown to be no better than placebo last year, for example.
But it might also have been odd for Lilly not to try again: with global populations ageing, incidence of diagnosis is set to rise and there is as yet no cure.
Lilly’s drug failed to meet its primary endpoints in both cognitive and functional tests in the EXPEDITION trials – but the company saw a crucial glimmer of light in one portion of the results.
Pre-specified secondary sub-group analyses of pooled data across both studies showed a statistically significant slowing of cognitive decline in patients with mild Alzheimer’s disease – hence the emphasis in the proposed new trial.
Added to this, the manufacturer is heavily involved in research in this therapy area, providing two compounds free of charge to US investigators conducting a worldwide trial of Alzheimer’s.
Lilly is to use Amyvid (Florbetapir F 18 Injection), developed by the company’s subsidiary Avid Radiopharmaceuticals, to assess potential trial participants.
The test, approved in the US and in Europe, is indicated for PET imaging of beta-amyloid neuritic plaque density in patients’ brains – but even though it is an advance, a positive Amyvid scan does not establish a diagnosis of Alzheimer’s or other cognitive disorder.
Amyloid beta is the main ingredient of brain plaques found in Alzheimer’s patients – but it is still impossible to be certain that a patient with raised levels of the plaques has Alzheimer’s.
The test should therefore only be used to suggest a negative diagnosis – that is, where patients have low levels of amyloid plaques, their cognitive decline is probably not due to Alzheimer’s.
However, despite its limitations the test is a step forward in diagnosing the disease, which is often advanced before patients are asked to take a standard mental reasoning test.
Adam Hill
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