Eli Lilly Initiates Phase III Clinical Trials of Next-Generation Aβ Monoclonal Antibody Remternetug for Early Symptomatic Alzheimer’s Disease

Recently, the China Drug Clinical Trial Registration and Information Disclosure Platform showed that Eli Lilly and Company initiated an international, multicenter, randomized, double-blind, placebo-controlled Phase III study (registration number: CTR20230785), aiming to evaluate the safety and efficacy of intravenous infusion of remternetug in subjects with early symptomatic Alzheimer's disease (AD) who have brain amyloid and tau pathology.

The study plans to enroll 140 participants in China and 1,300 participants internationally. Participants will be randomly assigned to receive either remternetug or saline placebo via intravenous infusion once every 12 weeks for a total of 3 dosing cycles. The primary endpoint is the change from baseline in iADRS score after 76 weeks of treatment in at least one population.

Alzheimer's disease is a neurodegenerative disorder that primarily occurs in the elderly, with clinical features including memory impairment, aphasia, apraxia, agnosia, visuospatial skill damage, executive dysfunction, as well as personality and behavioral changes, manifesting as comprehensive dementia. Statistical data shows that by the end of 2019, the number of Alzheimer’s patients in China exceeded 13 million cases, and this figure is expected to increase annually. The prevalence and mortality rates of AD in China are higher than the global average, with relevant data for women being higher than for men.

Eli Lilly stated that remternetug is the successor to donanemab and belongs to the "next-generation anti-amyloid antibody." Phase Ib clinical studies showed that remternetug demonstrated deep plaque clearance ability with a favorable safety profile. In this Phase III intravenous infusion study, the dosing regimen consists of a single dose per cycle, with a 12-week dosing interval, for a total of three cycles.

On February 22, Eli Lilly initiated a Phase III clinical trial (registration number: CTR20230358) for remternetug subcutaneous injection in treating patients with early symptomatic AD. The two studies plan to enroll 140 AD patients in China and 1,300 patients internationally.

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