Aribio said on the 9th that more than 95% of patients who completed the global phase 3 clinical trial of AR1001, an oral Alzheimer's disease treatment in development, have joined the additional extension study.
The company said the global phase 3 trial (POLARIS-AD) of AR1001 is in its final stage, enrolling 1,535 patients with early Alzheimer's disease at 230 sites in 13 countries.
According to the company, the trial was designed so that after the 52-week study ends, patients voluntarily decide whether to participate in an optional extension study (ExtensionStudy). The 52-week trial progress rate has exceeded 90%, and about 95% of those who completed dosing in the trial chose to take AR1001 for an additional year in the extension study. This is considered a rare level of high adherence in large-scale global Alzheimer's disease trials.
The company said, "This proves that patients, families, and medical staff deeply trust AR1001's strong efficacy and safety, as well as the convenience of an oral regimen, in real-world treatment," adding, "In particular, the mid-trial dropout rate is around 15%, well below the initial estimate of 25%, and is being managed favorably and stably."
The company expects that because AR1001 has a differentiated profile from existing injection-based antibody therapies, it will be a key factor in positioning the drug as a first-line treatment for Alzheimer's disease during the approval and commercialization process.
Fred Kim, head of Aribio's U.S. office, said, "The voluntary extension participation rate was higher than expected because patients and caregivers directly experienced AR1001's efficacy and safety," adding, "Accordingly, we manufactured additional clinical drug supply." He added, "This global phase 3 trial of AR1001 is scheduled to complete dosing in the second quarter this year, with a top-line readout in the third quarter, and the high extension participation rate and low mid-trial attrition will be an important foundation for enhancing confidence in the forthcoming clinical results."
Aribio will introduce the overall phase 3 program at the International Conference on Alzheimer's and Parkinson's Diseases (ADPD 2026), which opens in Copenhagen, Denmark, on the 17th. Sharon Sha, a Stanford University professor of neurology and director of the dementia center and a leading authority in Alzheimer's clinical research, will speak to present the status of the phase 3 trial of AR1001 and strategies for developing a first-line treatment for Alzheimer's disease.
It will also release exploratory clinical results for the noninvasive brain stimulation medical device "GVD-01." In the exploratory study, meaningful signals were observed, including improvements in cognitive function and cerebral blood flow markers in patients with early Alzheimer's.
Aribio is currently pursuing a merger with Solux, a KOSDAQ-listed company. The tentative merger date is June 5, but it could be delayed depending on the Financial Supervisory Service's review of the merger securities registration statement.