Interim analysis shows significant improvement in cognitive fluctuation and favorable quantitative EEG findings, with broader clinical trends favoring AR1005
SEONGNAM-SI, SOUTH KOREA, August 19, 2026 /EINPresswire.com/ — AriBio Co., Ltd., a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, today announced interim results from its ongoing Phase 2a clinical trial of AR1005 (NCT06537076) in patients with dementia with Lewy bodies. The findings were presented at the Alzheimer’s Association International Conference 2026 in London.
AR1005 is an investigational oral fixed-dose combination of lamotrigine, which inhibits voltage-gated sodium channels and reduces excessive excitatory neurotransmission, and rivastigmine, an approved treatment for cognitive symptoms. The Phase 2 trial is evaluating whether targeting neuronal hyperexcitability with this combination can mitigate cognitive and neuropsychiatric symptoms in patients with DLB. The ongoing study is being conducted at Severance Hospital in Korea and is expected to enroll 60 patients; the interim analysis included data from 31 participants.
At Week 20, AR1005 demonstrated a 1.15-point treatment difference in the Mayo Fluctuations Scale (MFS) in favor of AR1005 compared with placebo (95% CI: -2.17 to -0.12; p=0.030). MFS evaluates cognitive fluctuations, a characteristic and clinically important symptom of DLB, with lower scores indicating less severe symptoms.
The clinical finding was supported by quantitative electroencephalography (qEEG), where AR1005 showed lower theta-to-beta ratios (TBR), a measure associated with EEG slowing in DLB. The treatment difference was -3.34 globally (p=0.039), with similar findings in the central (-3.41; p=0.042) and occipital (-3.75; p=0.045) regions.
The interim analysis also showed a 0.46-point treatment difference in favor of AR1005 on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 20, although the difference was not statistically significant. Favorable numerical trends were also observed on the Korean Mini-Mental State Examination (K-MMSE) and the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI). The complete efficacy and safety profile will be assessed following completion of the study.
Professor Byoung-Seok Ye of the Department of Neurology at Severance Hospital, the principal investigator of the study, said:
“Dementia with Lewy bodies is associated with a range of symptoms, including cognitive decline, cognitive fluctuations, visual hallucinations, and parkinsonism, while available treatment options remain limited. The findings from this interim analysis provide early clinical data supporting further evaluation of AR1005, particularly in relation to cognitive fluctuations and quantitative EEG measures.”
Fred Kim, Managing Director at AriBio, said:
“These interim findings strengthen our conviction in targeting neuronal hyperexcitability in DLB. We have begun preparing for a pre-IND meeting with the FDA and will use the complete dataset to define the design and endpoints of a global Phase 2/3 program, with the goal of bringing a new treatment option to patients and families living with DLB.”
The findings are based on an interim analysis conducted before completion of enrollment. Final efficacy and safety results will be assessed after all 60 participants have completed the study.
About AriBio
AriBio Co., Ltd. is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases and other areas of high unmet medical need. The company’s lead program, AR1001, is an investigational oral treatment candidate for Alzheimer’s disease. AR1005 is an investigational oral therapy for Dementia with Lewy Bodies (DLB).
Tanya Xi
AriBio Co., Ltd.
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