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Alzheimer's, Dementia & Mental Health

Alzheimer’s Patients Show Significant Slowing of Decline with New Drug

Experimental drug Solanezumab that once got bad grades in Eli Lilly clinical trial bounces back

pill-making machineOct. 9, 2012 – The quest for a drug to treat Alzheimer’s disease continues its bumpy progress as Eli Lilly and Company announced yesterday that an experimental drug therapy called solanezumab targeting mild to moderate Alzheimer's disease, that did not meet their primary endpoints in August, has now produced a “statistically significant slowing of cognitive decline.” This second look at the Phase 3 data found the cognitive decline was slowed by 34 percent.

"Doctors called the results encouraging, although probably not good enough to win Food and Drug Administration approval of the drug without another study to confirm there is a benefit," reports The New York Times.

 

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This announcement followed the presentation of results from independent analyses of the EXPEDITION study data conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, at the annual meeting of the American Neurological Association (ANA).

The presentation was by Rachelle Doody, M.D., Ph.D., professor of Neurology and the Effie Marie Cain Chair in Alzheimer's Disease Research, Baylor College of Medicine, who is also a member of the steering committee for the ADCS.

"Alzheimer's disease research has been extremely challenging," said Dr. Doody. "The data results from the solanezumab Phase 3 trials were encouraging to the ADCS team. These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of AD therapies."

The Alzheimer’s Association had noted in a statement issued on August 24 that solanezumab was not out of the race for a treatment drug.

 “… there is new and encouraging information here. 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,” said the association’s statement.

“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.”

Lilly provided the raw data (the full data set collected from the EXPEDITION studies) to the ADCS. The ADCS statisticians then performed independent analyses of these data. These results were presented at the meeting.

"This is a complex disease that touches millions of people worldwide," said David Ricks, senior vice president and president, Lilly Bio-Medicines. "Alzheimer's disease causes significant burden on patients, caregivers and our society. While the path forward has not been determined, we believe these data in patients with mild disease may provide a step toward a potential treatment option."

Following is the report on the studies by Lilly.

Lilly Results from EXPEDITION1

The EXPEDITION1 study was designed with co-primary cognitive and functional endpoints (the Alzheimer's Disease Assessment Scale- Cognitive subscale and the Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL], respectively) in patients with mild-to-moderate Alzeimer's disease.

Lilly's pre-specified secondary analyses showed that results in patients with mild Alzheimer's disease taking solanezumab demonstrated a slowing of cognitive decline compared with placebo, as measured by the scale. This finding represented a 42 percent reduction in decline at the endpoint of the 18-month study. The difference in functional decline (ADCS-ADL) was not statistically significant.

Lilly Results from EXPEDITION2

Based on the results of EXPEDITION1, Lilly says it modified the statistical analysis plan (SAP) for EXPEDITION2, prior to database lock, to specify a single primary endpoint of cognition in patients with mild Alzheimer's disease as measured by the ADAS-Cog14, a 14-item scale, which includes three additional items considered relevant for patients with mild Alzheimer's disease.1 At the conclusion of EXPEDITION2, there was a 20 percent reduction in cognitive decline in patients with mild Alzheimer's disease taking solanezumab; however, the treatment difference was not statistically significant (p=.120). In the pre-specified secondary endpoint of ADCS-ADL, there was a 19 percent reduction in functional decline in patients with mild Alzheimer's disease treated with solanezumab, as compared with placebo; this difference was not statistically significant (p=.076).

Lilly Results from Pooled Analyses of EXPEDITION1 and EXPEDITION2

A pre-specified secondary analysis of pooled data in patients with mild Alzheimer's disease showed a slowing of cognitive decline (p=.001) compared with placebo, as measured by the ADAS-Cog14; this finding represented a 34 percent reduction in decline. In addition, the secondary analysis of the pooled data in patients with mild Alzheimer's disease showed a 17 percent reduction of functional decline as measured by the ADCS-ADL; however, the treatment difference was not statistically significant compared with placebo (p=.057).

A number of different biomarkers were assessed in the EXPEDITION studies. Some, but not all, of these biomarkers showed an effect of solanezumab. These additional data will be presented by the ADCS at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in Monte Carlo, Monaco, on October 29, 2012, or at subsequent medical meetings and in appropriate scientific venues.

In the EXPEDITION studies, the only adverse event with an incidence of at least 1 percent that occurred statistically significantly more in the solanezumab group than in the placebo group was angina (1.1 percent versus 0.2 percent). The incidence of vasogenic edema (ARIA-E) was approximately 1 percent, occurring in 11 patients treated with solanezumab and 5 patients on placebo, which was not statistically significant.

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