3/15/2024 0 Comments Icad antibodySafety and biomarkers, but not efficacy, are also what drove Lilly's Phase 2 testing of its γ-secretase inhibitor, which is currently enrolling for Phase 3 (see Fleisher et al., 2008). It instead ran a small and short (52 patients/3 months) Phase 2 trial that was heavily geared toward fluid biomarkers, and used those results as the basis to move into Phase 3 by 2009. But rather than running a sizable and long Phase 2 trial (230 patients/19 months in the case of Elan/Wyeth), and scrutinizing its results for hints for efficacy (see ARF ICAD story), Lilly decided to sidestep clinical efficacy entirely. Elan/Wyeth uses a humanized version of an N-terminal Aβ antibody that recognizes forms of Aβ peptide in amyloid plaques Lilly uses a mid-region antibody (m266) that captures soluble Aβ and tests the peripheral sink hypothesis of Aβ clearance ( DeMattos et al., 2002). Both competitors are developing a humanized therapeutic antibody, which would be the first biologic treatment for AD. At the International Conference on Alzheimer’s Disease, held 26-31 July in Chicago, the pharmaceutical company Eli Lilly and Company took the opposite approach to Elan/Wyeth. At this juncture, they sometimes base the decision on whether to start a long and costly Phase 3 program on less than rock-solid efficacy data (see ARF ICAD story). As new experimental drugs are getting ready for clinical testing against Alzheimer disease, it’s instructive to learn how pharmaceutical companies are navigating the transition from Phase 2 to 3.
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