[K-Bio Global Phase 3 | Special 2] Fred Kim, AriBio U.S. branch manager, “AR1001 aims to be the first treatment for early-stage Alzheimer’s”

Global phase 3 results released in November... Pay attention to the effects of the single administration group and the changes that patients will feel

Target to apply for FDA approval in 2027... Pursuing lower prices than existing antibody treatments

AriBio is developing ‘AR1001’, an oral Alzheimer’s disease treatment candidate, as a first-line treatment for early-stage patients. The plan is to confirm the effectiveness of the single-administration group in the global phase 3 clinical trial and increase treatment accessibility by ensuring ease of administration and price competitiveness.

Fred Kim, head of AriBio's U.S. branch, emphasized in an on-site Q&A that when evaluating the clinical results of AR1001, it is necessary to look at statistical significance as well as changes that patients can actually feel. The idea is that it is important to explain how much cognitive decline can be slowed while meeting the standards required for approval.

AR1001’s global phase 3 clinical trial ‘POLARIS-AD’ involved 1,535 patients with early-stage Alzheimer’s disease in 13 countries. The main results will be revealed for the first time at ‘CTAD 2026’, an Alzheimer’s disease clinical trial conference held in Boston, USA on November 16, 2026. Based on this, the company is preparing to apply for approval from the U.S. Food and Drug Administration (FDA) in 2027 and approval in 2028.

The following is a summary of the on-site Q&A according to the purpose of the remarks.

Q. What is the most important aspect of the phase 3 clinical trial results that will be released in November?

Director Kim: We are focusing on statistical significance to determine the success of the clinical trial. For approval and commercialization, it is important to meet established standards. Only then can the medicine be delivered to patients.

From the patient's perspective, what is important is what changes the results bring to their daily lives. A striking indicator is how much the decline in cognitive function can be slowed when taking medication and how much more time one can secure to live as oneself. As the results are released, the clinical significance of the data and its impact on patients will also be explained.

Q. Why do you emphasize the results of the single-administration group along with the entire patient group?

Governor Kim: Because we want to develop AR1001 as a first-line treatment. The goal is to enable patients to use drugs that are safe and easy to take from the stage of diagnosis of mild cognitive impairment caused by Alzheimer's disease.

To achieve this, it is important to obtain meaningful results in the single-administration group that is not used in combination with other Alzheimer's disease treatments. We aim to secure evidence for use as an initial treatment through analysis of the single-administration group.

Q. What is the range of patients targeted for first approval?

Director Kim: It targets early-stage Alzheimer’s disease. This includes mild cognitive impairment and mild dementia caused by Alzheimer's disease. Mild dementia is a stage in which daily life becomes more difficult due to cognitive decline.

First, the goal is to obtain permission within this range. In order to expand the scope of application in the future, a basis must be established through additional clinical trials and data accumulated in actual clinical settings.

Q. Are the 2027 approval application and 2028 approval goals agreed upon with the FDA?

Branch Manager Kim: The presented schedule is a goal that takes into account the time it normally takes to apply for and review a permit. The permit application materials are already being prepared, and the application process is planned to proceed after the announcement of the main results in 2026.

We are also preparing to shorten the period together with Fosun Pharmaceutical. If systems such as priority review can be used, there is a possibility of shortening the review period. After the announcement of the main results, we plan to hold a meeting with the FDA, and we will inform you as soon as the process progresses.

Q. In what direction do you plan to set the price?

Director Kim: Existing antibody treatments for Alzheimer's disease are priced in the range of 40 to 60 million won per year. AR1001 is planned to be supplied at a lower price. As the specific price must be decided through discussion with partners in each country, it will be disclosed as soon as it is confirmed.

Q. At what stage do you start taking it and how long do you take it?

Governor Kim: The first target for approval is early-stage Alzheimer's disease, including mild cognitive impairment and mild dementia caused by Alzheimer's disease. In order to expand the scope of application in the future, a basis must be established through additional clinical trials and data accumulated in actual clinical settings.

Chairman Jeong Jae-jun further explained the duration of the medication. Chairman Jeong said that once treatment for Alzheimer's disease is started, it is almost impossible to stop taking it and the patient takes it until the patient dies, which is why he is focusing on developing AR1001 as a first-line treatment.

AriBio is an oral medication taken once a day at home that aims to lower the treatment burden on patients and their families. After securing clinical evidence for early-stage Alzheimer's disease, the plan is to develop it as a treatment that can be used not only in specialized hospitals but also in primary healthcare Institutional Investors.