October 8, 2012 Update:
Eli Lilly announced the results of an independent secondary analysis of the drug solanezumab, which demonstrated a statistically significant 34 percent reduction in cognitive decline for patients in earlier stages of disease. The analysis was conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, and presented at the annual meeting of the American Neurological Association (ANA) 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. Eli Lilly is talking to the FDA about approval of solanezumab; however, the results of this study will first very likely need to be replicated in future clinical trials. The study is important because it lends credence to the theory that solanezumab, and similar drugs targeting a protein called amyloid beta, if given early in the disease process, could slow the progression of this degenerative brain disorder.
August 24, 2012 News Alert:
Eli Lilly opened a new chapter in Alzheimer's disease research today, following bitter-sweet results from a new drug trial. Following disappointing results announced by rival drug-makers Jansen and Pfizer earlier this month, the Lilly drug, Solanezumab, was widely expected to follow a similar course and to fail to improve cognitive performance in Alzheimer's disease patients.
While this result appears to have been true for the Lilly study overall, when investigators examined the data more closely, they saw a statistically significant improvement in the rate of cognitive decline in some patients. These better-performing patients tended to be in earlier stages of disease than those participants who showed no improvement. These findings are consistent with the insistence among many in the scientific community that these drugs would be most efficacious if delivered early in the course of the disease.
While unexpected, the conclusions are a welcome and promising sign for early-Alzheimer's cases. The results bode well for early-intervention therapies and lend new evidence to another question among researchers.
Historically, the majority of Alzheimer's research has centered on a particular set of factors involved in the development of toxic amyloid beta proteins, a hallmark of Alzheimer's disease. While a significant amount of genetic and other experimental data lends support to this "amyloid hypothesis," there have been concerns over the years that the amyloid hypothesis might not be the best lever to pull against Alzheimer's disease. A spate of clinical trials that targeted amyloid beta were halted in recent years, and this has fueled these concerns. The Lilly trial results may provide evidence that anti-amyloid strategies have a legitimate place in future Alzheimer's treatments.
For now, Lilly has much to consider. Among its decisions will be whether to pursue FDA approval now based on these positive findings among early-stage Alzheimer's disease patients. Alternatively, ultimate FDA approval may be more likely if Lilly first embarks on a formal clinical trial of solanezumab with early-stage Alzheimer's patients.