Posted on August 26, 2012 · Posted in Brain Injury

The results are out on the two late-stage clinical trials that Eli Lilly was running on a potential Alzheimer’s drug, and what you think about them depends on whether you tend to see the glass half empty or half full.

Lily’s tests on the drug solanezumab didn’t attain their goal, which was to stop Alzheimer’s progress, the drug maker announced last week.

This result marks the second recent setback for prospective Alzheimer’s drugs. Two week ago Pfizer and Johnson & Johnson announced that they were pulling the plug on a drug very similar to Lilly’s, called bapineuzumab. Both drugs act by blocking the overproduction of a protein found in the brain, beta amyloid, which has been present in  patients with Alzheimer’s.

However, Lilly’s good news was that its trials found signs that its drug could slow down the mental decline in patients with mild cases of Alzheimer’s.

Here’s how Lilly explained it in its press release.

“Eli Lilly and Co.  primary endpoints, both cognitive and functional, were not met in either of the two Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer’s disease. However, 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 subgroup 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.”

The pharmaceutical maker said it will continue with its clinical trials.

“We recognize 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,” Lilly Chairman John Lechleiter said in a statement. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.”

“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, executive vice president of science and technology, and president of Lilly Research Laboratories. “We believe the pooled data support the amyloid  hypothesis, as these are the first Phase 3 data with an anti-beta amyloid agent that appear to show a slowing of cognitive decline.”

An independent analysis of the data from the studies is being performed by the Alzheimer’s Disease Cooperative Study (ADCS), an academic national research consortium that facilitates the discovery, development and testing of new drugs for the treatment of Alzheimer’s disease.

ADCS will present its findings at the American Neurological Association (ANA) meeting in Boston on Oct. 8, and at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in Monte Carlo, Monaco, on Oct. 30

“The next steps for solanezumab have not yet been decided and will be determined after discussions with regulators,” Lilly said.

The two, Phase 3 double-blind, placebo-controlled solanezumab EXPEDITION clinical trials included more than 2,050 patients with mild-to-moderate Alzheimer’s disease in 16 countries around the world. The trials were 18 months long.










About the Author

Attorney Gordon S. Johnson, Jr.
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice :: 800-992-9447