Solanezumab is an experimental, humanized monoclonal antibody that binds to beta-amyloid. It is being studied as a potential therapy to delay the progression of Alzheimer’s disease. This disease is a chronic neurodegenerative disorder that results in a progressive decline in cognitive functions including memory, decision-making and language and ultimately leads to death. The drug is being developed by Eli Lilly & Company.
How Solanezumab Works
Solanezumab is a humanized monoclonal antibody that binds to soluble monomeric forms of beta-amyloid allowing it to be cleared before it clumps together to form beta-amyloid plaques. If beta-amyloid plays an important role in the formation of the amyloid plaques seen in the brains of patients with Alzheimer’s disease, as is hypothesized, then solanezumab could be a potential treatment for this high unmet medical need.
On August 24, 2012, Lilly announced that both of its Phase 3 trials in patients with mild-to-moderate Alzheimer’s Disease did not meet the primary endpoints of cognitive and functional benefit. 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. Based on these results, Lilly said that it is commencing an additional Phase 3 trial in patients with mild Alzheimer’s Disease. The new trial will enroll 2,100 patients with mild Alzheimer’s Disease with amyloid pathology confirmed by either PET scan or cerebrospinal fluid instead of 1,322 mild Alzheimer’s Disease patients in previous Phase 3 trials. There will be co-primary endpoints of ADAS-Cog14 (cognition) and ADCS-iADL (function) instead of ADAS-Cog11 and ADCS-ADL used in previous Phase 3 trials. It is estimated that patient enrollment will require 22 months beginning in September 2013 plus 18 months for patient follow up for a total of 40 months; i.e., data from the trial are estimated to be available in late 2016.
Patent and Know-How License
If solanezumab receives marketing authorization, PDL will receive a patent royalty of three percent for product manufactured and/or sold in the United States before expiration of our Queen et al. patents and a two percent know-how royalty on worldwide sales for 12.5 years from date of first commercial sale.