Lilly's Alzheimer's Drug Remternetug Granted IND Approval in China for Early-Stage Disease

According to the Smart Finance APP, on January 16, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Eli Lilly and Company (LLY.US)’s new Class 1 drug, remternetug injection, has received implied permission for clinical trials, intended for the development of treatment for early Alzheimer's disease.Public information shows that remternetug targets a subtype of amyloid protein called N3pG and is currently undergoing a Phase 3 clinical trial overseas for the treatment of patients with early Alzheimer's disease. Notably, donanemab injection, another Alzheimer's disease therapy developed by Eli Lilly that targets N3pG β-amyloid plaques, has recently been designated as a breakthrough treatment by the CDE.

It is reported that,The approval of remternetug for clinical trials in China means that this product will also enter the clinical research stage in China.

Screenshot source: CDE official website

Alzheimer's disease is a neurodegenerative disorder primarily associated with aging. The progression of the disease involves changes in thinking, memory, and behavior, and it ultimately advances to dementia within several years. Alzheimer's disease is not a normal part of aging; complex changes occur in the brain up to 20 years before symptoms appear, eventually leading to the death of brain cells or loss of connections.

Research has found that Alzheimer's disease is characterized by cognitive impairment caused by synaptic loss and neuronal death, with extracellular β-amyloid plaques being one of its pathological hallmarks. Targeting amyloid proteins is one of the key directions in the development of new drugs for Alzheimer's disease. Recently (January 7), the U.S. FDA also approvedThe Second ClauseInnovative Alzheimer's Disease Therapy Targeting β-Amyloid Protein.

According to publicly available information from Eli Lilly and Company, remternetug (LY3372993) isA Next-Generation N3pG Amyloid Antibody with a Flexible Dosing Regimen, including subcutaneous administration, to meet the diverse needs of Alzheimer's patients. Previously, the productHas demonstrated deep plaque clearance consistent with amyloid-lowering levels in Phase 1b clinical trials, and has shown good safety.。

Screenshot source: Eli Lilly 2021 R&D Day PPT

According to the ClinicalTrials website, there are currently two clinical trials underway for remternetug, one of which isTRAILRUNNER-ALZ 1, a randomized, double-blind, placebo-controlled, Phase 3 study, aimed to evaluate the safety and efficacy of the candidate drug in patients with early symptomatic Alzheimer's disease. The trial plans to enroll a total of 400 participants in the United States and Japan, and the subjects willBy subcutaneous injection or intravenous infusionReceive remternetug or placebo treatment.