AR1005 / ariBio - LARVOL DELTA

AriBio’s AR1005 shows early efficacy signals in Lewy body dementia phase 2a trial (Korea Biomedical Review) - "The randomized, double-blind phase 2a study is being conducted at Severance Hospital in Korea and is expected to enroll 60 patients with Lewy body dementia. The interim analysis included 31 patients who had reached 20 weeks of treatment...On the Mayo Fluctuations Scale, which measures cognitive fluctuations commonly experienced by patients with Lewy body dementia, the adjusted mean score was 0.77 in the AR1005 group, compared with 1.92 in the control group. The difference was statistically significant, with a p-value of 0.030...At week 20, the AR1005 group showed a 0.46-point improvement relative to the control group. From baseline, the control group worsened by 0.34 points, while the AR1005 group improved by 0.16 points....'Based on the interim analysis, we will quickly refine the design and regulatory strategy for a global phase 2/3 trial and accelerate the candidate’s development toward commercialization.'"

P2a data • Dementia • Lewy Body Disease

Efficacy And Safety Of AR1005 In Patients With Dementia With Lewy Bodies: A Randomized, Double-blind, Phase 2a Trial In Progress (AAIC 2026) - No abstract available

Clinical • P2a data • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Aribio joins Lilly TuneLab to boost AI-driven CNS drug development (Chosun Biz) - "Through this participation, Aribio aims to advance data-driven decision-making across its neuroscience pipeline and increase the precision and likelihood of success in developing therapies that improve the disease itself beyond relieving symptoms...Aribio is currently operating its own AI-based drug discovery platform, ARIDD (AI-powered, Rapid and Integrated Drug Development). The platform is being used to develop AR1001, an oral, polypharmacological Alzheimer's disease candidate that targets multiple causal pathways simultaneously, and AR1005, a candidate therapy for dementia with Lewy bodies."

Licensing / partnership • Alzheimer's Disease • Dementia • Lewy Body Disease

Safety and Efficacy of AR1005 in Patients With Lewy Body Disease (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Yonsei University

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Aribio receives IND approval for Phase 2 clinical trial for Lewy body dementia treatment [Google translation] (Asia Economy) - "Aribio recently announced that it received approval for a domestic phase 2 clinical trial (researcher clinical trial) trial plan (IND) for AR1005 from the Ministry of Food and Drug Safety....This phase 2 clinical trial is a researcher clinical trial to confirm effectiveness and safety and will be conducted at a single institution at Severance Hospital, led by Professor Byeong-seok Ye of the Department of Neurology at Severance Hospital as the main researcher. A total of 60 patients will take AR1005 for 20 weeks, and imaging techniques and biomarker research will be conducted to accurately diagnose Lewy body dementia. The plan is to begin recruiting patients at the end of this year and announce the top line clinical results as early as the end of next year."

New P2 trial • CNS Disorders • Dementia • Lewy Body Disease