Eli Lilly and Company's Alzheimer's disease treatment Kisunla (generic name donanemab) has entered domestic procedures for a global clinical trial in patients with Lewy body dementia. Attention is focused on whether Kisunla, approved as an Alzheimer's disease treatment, can expand its treatment scope to Lewy body dementia, the second most common dementia after Alzheimer's.
According to the industry on the 12th, Korea Lilly received approval for a global phase 2 clinical trial plan (IND) for Kisunla from the Ministery of Food and Drug Safety on the 10th. The trial will involve patients showing key clinical symptoms of early cognitive impairment or Lewy body dementia. Researchers plan to compare the donanemab treatment group with a placebo group to evaluate safety and efficacy.
In Korea, Ewha Womans University Mokdong Hospital, Inha University Hospital, Gangnam Severance Hospital, Severance Hospital, Konkuk University Hospital, and Hanyang University Hospital will participate.
Alzheimer's disease is a representative neurodegenerative brain disorder caused by the abnormal accumulation of beta-amyloid and tau proteins. Kisunla is an anti-amyloid antibody therapy that targets and clears beta-amyloid to slow disease progression.
In a global phase 3 clinical trial involving 1,736 patients with early Alzheimer's disease, Kisunla was shown to significantly slow declines in cognitive function and ability to perform activities of daily living. Lilly obtained U.S. Food and Drug Administration (FDA) approval based on these results and is expanding approvals to the United States, Japan, China, the United Kingdom, Australia, and the European Union (EU).
In particular, Kisunla is designed to allow discontinuation of dosing once amyloid plaques in the brain are reduced below a set threshold. The company expects this to reduce patients' treatment burden and expense.
The trial is noteworthy as an attempt to broaden the application beyond Alzheimer's disease to Lewy body dementia. Lewy body dementia is the second most common degenerative dementia after Alzheimer's, with core symptoms that include hallucinations, cognitive decline, and Parkinson's disease–like motor disturbances.
The disease occurs as "Lewy bodies," formed by the abnormal accumulation of alpha-synuclein (α-synuclein) protein within brain cells, impair neuronal function. Current treatments focus on alleviating symptoms such as cognitive decline or hallucinations, and there are still no therapies that slow disease progression or target its cause.
The industry expects the trial results to indicate a direction for developing Lewy body dementia treatments.