Eli Lilly Reports Promising Early Results for Next-Generation Aβ Monoclonal Antibody Remternetug in Phase I Alzheimer's Trial

On March 31, according to Fierce Biotech, Eli Lilly's new Alzheimer's drug remternetug appeared to achieve early, dose-dependent reductions in amyloid plaques in a small-scale Phase I study, but also showed common adverse effects of anti-amyloid monoclonal antibodies, namely amyloid-related imaging abnormalities (ARIA).

Remternetug is an investigational IgG1 monoclonal antibody that targets the pyroglutamate modification of the third amino acid in amyloid-beta peptides, which are found exclusively in cerebral amyloid plaques.

At the Alzheimer's and Parkinson's Diseases (AD/PD) Conference held in Sweden, Eli Lilly presented Phase I study data for remternetug. In the interim analysis, 41 patients with mild cognitive impairment or mild to moderate dementia due to Alzheimer’s disease were randomly assigned to receive either placebo or different doses of remternetug every four weeks. They underwent PET imaging screenings on Day 85 and Day 169.

The results showed that Eli Lilly found remternetug achieved "rapid and powerful" plaque clearance. All dose groups in the trial showed a dose-dependent reduction in amyloid protein, although the smaller 250mg dose had a less robust response at day 85 compared to higher doses. By day 169, 18 out of 24 treated patients achieved amyloid clearance.

In terms of safety, Eli Lilly reported a common adverse reaction associated with this class of drugs, amyloid-related imaging abnormalities (ARIA), a side effect that has been troubling Eisai and Biogen's approved therapy Leqembi. In Eli Lilly’s study, 10 out of 41 patients experienced ARIA, with 24 patients receiving remternetug treatment. Only one of these events was classified as a serious adverse reaction.

In a more detailed presentation of the results, this serious adverse reaction occurred in the 700-1400mg dose group and was marked as ARIA-E (cerebral edema), ARIA-H (cerebral hemorrhage), and "suicide attempt." Additionally, across all study groups, a total of 9 patients discontinued the medication.

A spokesperson for Eli Lilly told Fierce Biotech via email: "In the data we submitted to AD/PD, one participant experienced a serious adverse event due to ARIA, which resolved after discontinuation of the drug and oral steroid treatment." The spokesperson confirmed that all other ARIA events were asymptomatic, with ARIA-E being the most common treatment-emergent adverse reaction, occurring in 10 patients.

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