Solanezumab
Publisher: Datamonitor Healthcare
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Analyst Outlook
Eli Lilly’s solanezumab is the most clinically advanced amyloid-beta monoclonal antibody (MAb) in the
pipeline, having already undergone two global Phase III trials. While these studies, EXPEDITION 1 and
EXPEDITION 2, failed to provide sufficient evidence to support regulatory filing in mild to moderate
Alzheimer’s disease, they did demonstrate a sign of efficacy in mild Alzheimer’s disease, which Eli Lilly
is now investigating in a third study, EXPEDITION 3. Although this third trial could delay any potential
regulatory filing by several years, it will provide more conclusive evidence for the drug’s disease-
modifying properties and cognitive benefit in the more appropriate mild Alzheimer’s disease
population. In addition, Eli Lilly is extending solanezumab’s efficacy evaluation to the prodromal
population and to patients at risk of developing Alzheimer’s disease. However, although the current
data is statistically significant, there is a danger that solanezumab’s slight effect on slowing cognitive
decline is not necessarily relevant for clinical practice.
Drug Overview
Solanezumab is a humanized version of mouse antibody m266, an immunoglobulin G1 MAb that
recognizes a central primary sequence epitope on amyloid-beta (Alzforum, 2015). Solanezumab is
believed to bind specifically to soluble amyloid-beta and thereby alters the sticky characteristics of
this peptide (Lemere and Masliah, 2010). The binding and removal of soluble amyloid-beta by
solanezumab could lead to the dissolution of amyloid-beta plaques, which may result in slowing
disease progression.
Eli Lilly has already completed two global Phase III trials of solanezumab in patients with mild to
moderate Alzheimer’s disease. However, the failure of solanezumab to meet its primary endpoints in
these pivotal trials has forced Eli Lilly to redesign its clinical program and instead target the mild
Alzheimer’s disease subset. This setback means that solanezumab is unlikely to reach the market
before 2017.
Following the discontinuation of intravenous bapineuzumab (Johnson & Johnson/Pfizer), solanezumab
is now the leading amyloid-beta antibody in clinical development.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 solanezumab : Alzheimer’s disease
LIST OF FIGURES
14 Figure 1: Solanezumab for Alzheimer’s disease – SWOT analysis
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of solanezumab in Alzheimer’s
disease
16 Figure 3: Datamonitor Healthcare’s drug assessment summary of solanezumab in Alzheimer’s
disease
LIST OF TABLES
4 Table 1: Solanezumab drug profile
6 Table 2: Solanezumab Phase III data in Alzheimer’s disease
10 Table 3: Solanezumab Phase III trials in Alzheimer’s disease
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