Lilly’s Alzheimer’s drug fails in phase III
pharmafile | August 24, 2012 | News story | Sales and Marketing | Alzheimer's, EXPEDITION, lilly, solanezumab
Lilly has announced that its Alzheimer’s drug candidate solanezumab has failed its primary endpoints in two key phase III trials.
The news is another heavy, blow to the field, which has seen disappointment after disappointment in late-stage drug candidates.
However the failure rate in the Alzheimer’s drug field meant that the news was not unexpected. Moreover, Lilly say that there is still hope that the drug could help some patients.
Solanezumab was the last remaining drug to have reached phase III, after Pfizer and Johnson & Johnson’s bapineuzumab failed to show any meaningful impact on the disease, in results released at the beginning of August.
Lilly’s drug failed to meet its primary endpoints in both cognitive and functional tests, which were not met in either of the two phase III, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild- to-moderate Alzheimer’s disease.
But the company is not ready to declare defeat just yet, as it says one analysis gives hope the drug could help some sufferers. A pre-specified secondary analysis of pooled data across both trials showed statistically significant slowing of cognitive decline in the overall study population of patients with mild-to-moderate Alzheimer’s disease.
In addition, 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, but not in patients with moderate Alzheimer’s disease.
“We recognise that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline,” said John Lechleiter, chairman, president and chief executive, Lilly. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.”
Adverse events with an incidence of at least 1% that occurred statistically significantly more in the solanezumab group than in the placebo group were lethargy, rash and malaise (in EXPEDITION1) and angina (in EXPEDITION2).
An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled and will continue as planned.
“Lilly is committed to finding medicines that alter the underlying pathology of Alzheimer’s disease for the benefit of patients and their loved ones,” said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. “We believe the pooled data support the amyloid hypothesis, as these are the first phase III data with an anti-beta amyloid agent that appear to show a slowing of cognitive decline.”
An independent analysis of the data from the EXPEDITION studies is being performed by the Alzheimer’s Disease Co-operative Study (ADCS), an academic national research consortium that facilitates the discovery, development and testing of new drugs for disease. ADCS will present their findings at the American Neurological Association (ANA) meeting in Boston, Mass., on 8 October, 2012, and at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in Monte Carlo, Monaco, on 30 October, 2012.
Lilly says it has not yet decided the next steps for the molecule, and will make a final decision after discussing its potential with regulators.
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