13 December 2012. Eli Lilly announced yesterday that it plans to conduct a new Phase 3 trial of its anti-amyloid antibody, solanezumab. The trial will test the passive immunotherapy in patients with mild Alzheimer's disease. The decision comes after analysis of two earlier Phase 3 trials in EXPEDITION and EXPEDITION2 indicated that the treatment had a small benefit only in the patients with mild AD. According to a company press release, details of the new trial are still being ironed out. After consultation with officials at the Food and Drug Administration, the company decided not to seek approval of the drug in the U.S. based on the EXPEDITION trials alone. The company will consult with regulatory agencies worldwide and, according to its statement, may pursue different approaches for approval in different jurisdictions.
To date, solanezumab is the only anti-Aβ therapy to have shown a positive, albeit very small, effect in Phase 3. While primary endpoints were missed (see ARF related news story), Lilly’s as well as an independent analysis of the EXPEDITION trials run by the Alzheimer's Disease Cooperative Study showed that the therapy appeared to slow cognitive decline by about one-third after 18 months of treatment. Patients with mild AD also had some slowing of functional decline compared to those on placebo (see ARF related news story). Solanezumab was selected as one of three therapies in an upcoming prevention trial in people with familial AD mutations (see ARF related news story).—Tom Fagan.