AriBio to Unveil Pivotal Phase 3 POLARIS-AD Topline Results for Oral AR1001 in Alzheimer’s Disease at CTAD 2026

First oral session reports 52-week efficacy and safety of AR1001, an investigational daily oral therapy designed to slow early Alzheimer’s disease progression.

SEONGNAM-SI, SOUTH KOREA, November 9, 2026 /EINPresswire.com/ -- AriBio Co., Ltd., a leading Korean based biotechnology company dedicated to advancing treatments for neurodegenerative diseases, today announced that topline results from its pivotal Phase 3 trial, POLARIS-AD, will be presented at the 19th Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place November 16–19, 2026, in Boston. Dr. Sharon Sha, Chief, Memory Disorders Division at Stanford University and Global Principal Investigator of POLARIS-AD, will present the findings during the conference’s first oral communications session on Monday, November 16th, at 4:05 p.m. EST.

The presentation will include topline efficacy and safety outcomes from the 52-week double-blind study. CTAD has highlighted POLARIS-AD among the significant clinical trial readouts featured in this year’s program.

AR1001 is being developed to address the need for an oral treatment that could slow the progression of Alzheimer’s disease. It has the potential to become the first FDA-approved oral disease-modifying therapy for AD. In the Phase 2 study, AR1001 was generally well tolerated, with a safety profile similar to placebo. Biomarker analyses showed reductions in plasma phosphorylated tau (p-tau181 and p-tau217) and glial fibrillary acidic protein (GFAP) with AR1001 30 mg compared with placebo, suggesting disease-modifying effects. Preclinical research suggests that AR1001 may act on multiple pathways implicated in Alzheimer’s disease, offering an additional therapeutic approach to the disease’s complex biology. POLARIS-AD will provide pivotal evidence on the efficacy and safety of this once-daily oral treatment.

“POLARIS-AD was designed to evaluate whether a once-daily oral treatment could offer a meaningful new option for people living with early Alzheimer’s disease,” said Jai-Jun Choung, Ph.D., Chairman and Chief Executive Officer of AriBio. “Our goal is to develop an oral therapy that can slow disease progression and be practical for patients and care partners to use globally and over the long term. We look forward to presenting the findings at CTAD and discussing their implications with the international research community. We are grateful to the participants, care partners, investigators and clinical teams whose commitment made this global study possible.”

Presentation Details

• Title: POLARIS-AD: A Global Phase 3 Trial of AR1001 in Early Alzheimer’s Disease: Efficacy Outcomes at 52 weeks and Safety Through the Extension Phase

• Date: Monday, November 16, 2026

• Time: 4:05 p.m. EST

• Session: First oral communications session, 3:50–4:50 p.m. EST

• Presentation number: OC2

• Location: CTAD 2026, Boston, Massachusetts

AriBio will also present two posters at CTAD 2026:

P515 — Biotech Showcase: AriBio: Building an Oral Therapeutic Franchise Across Alzheimer’s Disease and Related Dementia, with Phase 3 AR1001 and Phase 2 AR1005

P135 – Remote: AI-Assisted Review Support Tool for Clinical Operations and Data Reconciliation in a Global Phase 3 Alzheimer’s Disease Trial

About POLARIS-AD 

POLARIS-AD (NCT05531526) is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating AR1001 in participants with early Alzheimer’s disease. The study enrolled 1,535 participants across approximately 230 clinical sites in 13 countries. Participants received AR1001 30 mg or placebo once daily for 52 weeks. The primary endpoint is change from baseline to Week 52 in the Clinical Dementia Rating–Sum of Boxes (CDR-SB), a measure of cognitive and functional impairment. Additional assessments evaluate cognition, daily functioning, and biomarkers associated with Alzheimer’s disease. A total of 1,348 (88%) participants completed the 52-week treatment period. More than 95% of eligible participants completing the main study opted to continue in the optional long-term extension study, in which all participants receive AR1001.

About AR1001

AR1001 is an investigational, disease-modifying, once-daily oral small molecule developed by AriBio for Alzheimer’s disease and other neurodegenerative disorders. AR1001 is a blood-brain barrier-penetrant phosphodiesterase-5 (PDE5) inhibitor that enhances cyclic guanosine monophosphate (cGMP) signaling. Preclinical research supports its potential to act on multiple biological pathways implicated in Alzheimer’s disease, including cerebral perfusion, neuroprotection, neuroinflammation and tau phosphorylation. AR1001 is being evaluated in the global Phase 3 POLARIS-AD trial for early Alzheimer’s disease. AR1001 has not been approved by the U.S. Food and Drug Administration or any other regulatory authority, and its safety and efficacy have not been established.

About AriBio

AriBio Co., Ltd. is a late clinical-stage biotechnology company headquartered in South Korea, with global clinical operations in San Diego, California, 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 a Phase 2 oral candidate for the treatment of Dementia with Lewy Bodies. AriBio is also advancing additional programs in dementia and related neurological disorders.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the planned presentation of POLARIS-AD topline results at CTAD 2026, the timing of AriBio’s related results announcement, the potential therapeutic benefits of AR1001, and the future development of AriBio’s pipeline. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, uncertainties associated with clinical trial analyses and interpretation, the ability to demonstrate safety and efficacy, future regulatory review and approval, changes to conference schedules or disclosure requirements, and other factors that may affect the timing of the presentation or announcement. AR1001 is an investigational treatment candidate for Alzheimer’s disease, and its safety and efficacy for this indication have not been established. AR1005 is a Phase 2 oral candidate for the treatment of Dementia with Lewy Bodies, and its safety and efficacy have not been established. AriBio undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

Fred Kim, Managing Director
AriBio Co., Ltd.