Aribio Receives IND Approval for Phase 2 Clinical Trial of Luisoche Dementia Treatment

Aribio is continuously expanding its dementia-related pipeline by actively developing 'AR1001,' an early Alzheimer's dementia treatment, 'AR1004,' a mild cognitive impairment (MCI) treatment, and now 'AR1005,' a Lewy body dementia treatment.

Jaejun Jeong, CEO of Aribio. Photo by Hyunmin Kim kimhyun81@

Aribio recently announced that it received approval from the Ministry of Food and Drug Safety (MFDS) for the domestic Phase 2 clinical trial (investigator-initiated trial) of AR1005. Currently, Aribio is conducting a global Phase 3 clinical trial for AR1001, has obtained IND approval for the domestic Phase 2 trial of AR1004, and has now succeeded in gaining Phase 2 approval for AR1005 as well.

This Phase 2 trial is an investigator-initiated clinical study to verify efficacy and safety, led by Professor Ye Byung-seok of the Neurology Department at Severance Hospital, a single institution. A total of 60 patients will take AR1005 for 20 weeks, and imaging techniques and biomarker studies for the accurate diagnosis of Lewy body dementia will also be conducted. Patient recruitment is planned to begin by the end of this year, with top-line clinical results expected as early as the end of next year.

Aribio entered this Phase 2 trial through joint research and development (R&D) efforts with Severance Hospital as part of the research-oriented hospital dementia unit project. Samjin Pharmaceutical, which participates in Severance Hospital’s metabolic dementia research-oriented hospital project alongside Aribio, is scheduled to manufacture the clinical drug and has also begun formulation development to improve the medication.

Lewy body dementia is known to be the second most common cause of degenerative dementia after Alzheimer's disease. It is named after the Lewy bodies, which are deposits of the protein alpha-synuclein found inside the cerebral cortex neurons of patients. Characteristic symptoms include cognitive decline, visual hallucinations, REM sleep behavior disorder, and Parkinsonian motor symptoms.

Although approximately 3.8% of dementia patients are diagnosed with Lewy body dementia, pathological diagnosis in dementia patients shows a much higher rate of 15?50%, suggesting that the actual number of patients may be greater. Currently, cholinesterase inhibitors such as rivastigmine are commonly used for Lewy body dementia patients, but these are limited symptom-relieving agents without fundamental therapeutic effects.

Aribio explains that the oral drug AR1005 reduces the activity of neuronal sodium channels and increases major neurotransmitters that inhibit the central nervous system, thereby improving neuronal hyperexcitability observed in patients with Lewy body disease.

In addition to this, Aribio is developing 'AR1002' (currently in preclinical stages), targeting tau pathology Alzheimer's disease, and 'AR1003' (preclinical stage completed), aimed at mild to moderate Alzheimer's disease.

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