Eli Lilly's Next-Generation Anti-Amyloid Beta Monoclonal Antibody Remternetug Granted Breakthrough Therapy Designation in China for Early Alzheimer’s Disease

On April 11, the CDE website showed that Eli Lilly's remternetug injection is proposed to be included in the breakthrough therapy, for the treatment of patients with early Alzheimer's disease (AD).

Alzheimer's disease is a neurodegenerative disorder that primarily occurs in the elderly, with clinical features including memory impairment, aphasia, apraxia, agnosia, damage to visuospatial skills, 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 Alzheimer’s disease (AD) in China are higher than the global average, and relevant data for women are higher than those for men.

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. Eli Lilly has stated that remternetug is the successor to donanemab and belongs to the "next-generation anti-amyloid antibodies."

Interim analysis of Phase Ib clinical study found that remternetug demonstrated deep plaque clearance ability, with all dose groups showing dose-dependent reductions in amyloid plaques. However, the response of the smaller 250mg dose at Day 85 was not as robust as that of the higher doses. By Day 169, 18 out of 24 treated patients achieved amyloid plaque 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 consistently troubled 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 "suicidal attempt." Additionally, across all study groups, a total of 9 patients discontinued the medication.

Eli Lilly and Company launched two international multicenter, randomized, double-blind, placebo-controlled Phase III clinical trials (registration numbers CTR20230358 and CTR20230785) for remternetug subcutaneous injection and intravenous injection in treating patients with early symptomatic AD on February 22, 2023, and March 15, 2023, respectively.

Two studies plan to enroll 140 AD patients in China and 1,300 patients internationally to evaluate the safety and efficacy of remternetug administered via subcutaneous injection and intravenous infusion in early symptomatic AD subjects with brain amyloid and tau pathology. The primary endpoint for both studies is the change in iADRS score from baseline after 76 weeks of treatment in at least one population.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Wonderful Live Broadcast

CUBE LIVE

↑ Click to scan the QR code and reserve a live stream ↑

Medcube Reader Survey Questionnaire

Thank you for your companionship. Looking forward to your feedback.

Scan the QR code to provide valuable suggestions