[Edaily Reporter KIM SAE-MI ] “We are the first to venture down a path that no one else has taken.”

Fred Kim, head of AriBio’s U.S. branch, made this remark on the 9th at the E-Daily “K-Bio Deal Summit 2026,” held at KG Harmony Hall in KG Tower, Jung-gu, Seoul, explaining the background behind AriBio’s decision to independently conduct global Phase 3 clinical trials for its Alzheimer’s disease treatment. On that day, Kim delivered a presentation titled “The Global Clinical Development Journey and Commercialization Strategy for AR1001, an Oral Alzheimer’s Disease Treatment.”

AR1001 is a once-daily, oral treatment candidate for early-stage Alzheimer’s disease belonging to the phosphodiesterase 5 (PDE5) inhibitor class. AriBio has completed the global Phase 3 clinical trial “POLARIS-AD” and is currently conducting data cleaning.

Unlike existing Alzheimer’s disease treatments such as “Leqembi” and “Kisunla,” which focus on amyloid removal, AR1001 adopts a multi-mechanism approach. Through PDE5 inhibition, it simultaneously aims to increase cerebral blood flow, protect neurons, boost levels of nerve growth factor and brain-derived neurotrophic factor (BDNF), and inhibit tau hyperphosphorylation.

AriBio decided to conduct the global Phase 3 trial independently because the use of PDE5 inhibition to treat Alzheimer’s disease is an approach unfamiliar to big pharma, making it necessary for the company to demonstrate its potential through its own clinical trials. Managing Director Kim explained, “In the U.S. Phase 2 clinical trial, we confirmed long-term safety, improvements in biomarkers, and cognitive function improvements in certain patient subgroups,” adding, “Based on these results, we decided to prove the drug’s efficacy directly in the Phase 3 trial.”

The outcome of AR1001’s global Phase 3 clinical trial is expected to become clear this November. President Kim said, “We are currently cleaning the data and plan to present the global Phase 3 topline results orally at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in mid-November,” adding, “We, too, are filled with anticipation every single day.” He added, “We plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of next year.”

Aribio envisions evolving beyond AR1001 to become a comprehensive solutions provider covering the full spectrum of degenerative brain diseases. “Although we are known primarily for AR1001, we are actually a biotech company dedicated to developing integrated solutions for brain diseases,” emphasized President Kim. “We aim not only to reduce the burden on patients through an oral treatment but also to simplify diagnosis and improve access to treatment.”

The company’s strategy is to expand indications to include vascular dementia and Parkinson’s disease, while simultaneously developing follow-up new drugs, biomarkers, and medical devices to establish a brain disease platform that encompasses everything from diagnosis to treatment.