How Much Amyloid Clearance, How Fast Is Needed To Slow Alzheimer’s?
Questions Remain But CTAD Data Offer Clues
Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.
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The first clinical trial results for Roche’s brain shuttle technology in Alzheimer’s patients showed that trontinemab cleared more amyloid and at a faster pace than its failed predecessor gantenerumab.
Solanezumab did not reduce the risk of progression in preclinical Alzheimer’s disease in the Phase III A4 study but it provided evidence that removing amyloid plaques – the mechanism of action for Lilly’s two remaining Phase III AD therapies, donanemab and remternetug – may be the key to efficacy.
More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.