In October 2012, Eli Lilly and Company released results of its Expedition trials, two Phase 3, double-blind, placebo-controlled studies of the anti-amyloid antibody solanezumab, in patients with mild-to-moderate Alzheimer’s disease.
Although cognitive decline was slowed in patients with early stage disease in one trial, and there were also positive signs from the other trial, those findings were not statistically significant. But a secondary analysis conducted independently by a panel of academic researchers pooled data from trial participants with mild Alzheimer’s, showing a 34% reduction in cognitive decline, strengthening the idea that treatments should target earlier stages in disease.
BIOtechNOW asked neurologist Eric Siemers, the medical director of Eli Lilly’s Alzheimer’s disease team, about the broader challenges ahead.
Q: What is one major roadblock to coming up with disease-modifying treatments for Alzheimer’s?
One of the big questions we as an industry previously faced was, ‘How do we best design and evaluate Phase 2 clinical trials to help improve the probability of success in large Phase 3 studies?’ Lilly developed an approach to use biomarkers in our Phase 2 studies, and based on the data of the Phase 3 solanezumab Expedition studies, I believe we are on the right track with this approach for earlier phase trials.
Q: What are the challenges of coming up with better biomarkers that can help catch AD before symptoms start to show?
Recently, substantial progress has been made using PET ligands and spinal fluid biomarkers that can help us better identify patients who may be on the path to developing Alzheimer’s disease. The next step will be to build clinical trials with these new tools that we now have available to us.
Q: What are your AD research/treatment goals?
At Lilly, we are committed to discovering and developing innovative diagnostics and medicines that have the potential to diagnose and slow the progression of Alzheimer’s disease. We have a robust preclinical and clinical development pipeline focused on this important therapeutic area. As part of this commitment, we also share the Health and Human Service Agency’s goal of preventing and effectively treating Alzheimer’s disease by 2025.
This is an area with unmet huge medical need. Alzheimer’s Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year (which implies one new case every four seconds). The number of people affected is estimated to be over 115 million by 2050. Estimates vary, but experts suggest that as many as 5.4 million Americans may have Alzheimer’s disease. Lilly is committed to finding medicines for the millions of patients and their loved.