Therapy Type: Immunotherapy (passive) (timeline)
Target Type: Amyloid-Related (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 1)
Company: Eli Lilly & Co.
Developed originally at MedImmune, now part of AstraZeneca, this antibody is being developed jointly by AstraZeneca and Eli Lilly. AN1814 binds to monomeric Aβ42. According to researchers at Lilly, AN1814 is not being developed based on its peripheral binding and the peripheral sink hypothesis, as was solanezumab, a prior antibody targeting monomeric Aβ 40 ad 42. Rather, AN1814 development will focus on CNS compartments (pers. communication).
In February 2014, AstraZeneca started a multicenter Phase 1 trial in the United States, which was to enroll 242 people with mild to moderate Alzheimer's disease. The study will evaluate single and multiple ascending doses of intravenously and subcutaneously delivered antibody and placebo. Outcomes include measures of safety, pharmacokinetics, and immunogenicity of the antibody, as well as pharmacodynamics of blood and CSF Aβ concentrations. This trial will also correlate results with ApoE genotype and test the usefulness of a new cognitive tool called MCI screen. In 2015, the enrollment target was reduced to 121. The trial is set to run until 2017. See clinicaltrials.gov.
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