Aribio: 95% of AR1001 Phase 3 Completers Opt for Additional Extension Study

Aribio announced on November 5 that the global Phase 3 clinical trial (POLARIS-AD) of its oral Alzheimer's treatment AR1001 has surpassed an 80% progress rate, with over 95% of patients who completed dosing now participating in an additional extension study.

According to the company, more than 500 patients have completed the 52-week dosing period in the AR1001 Phase 3 trial. Of these, over 95% chose to receive an additional year of active treatment.

The POLARIS-AD trial has completed patient enrollment of 1,535 participants across 13 countries. After a 52-week double-blind dosing and evaluation period, participants are offered an additional 52 weeks of open-label active treatment. The company is operating the extension study at its own expense to ensure continuity of care for patients and caregivers, as well as to collect long-term safety and sustained efficacy data.

Aribio stated, "Voluntary participation in the additional extension study reflects patients' real-world experience of AR1001's efficacy and safety." In an interim analysis, 41.8% of patients who completed AR1001 dosing maintained or improved cognitive function according to the U.S. Food and Drug Administration (FDA) key indicator (CDR-SB). In comparison, a similar analysis of Kisunla showed that 37.7% of Phase 3 trial patients did not experience symptom worsening.

Furthermore, the risk of brain edema or brain hemorrhage (ARIA-E/H), commonly reported with antibody injection therapies, has not been observed in the AR1001 Phase 3 trial to date. In contrast, ARIA-related adverse reactions have been reported in approximately 21.5% of patients treated with Leqembi (lecanemab) and about 36.8% of those treated with Kisunla (donanemab).

Fred Kim, Head of Aribio USA, said, "The extension study is a stage where all participants receive the active drug, allowing patients to directly experience AR1001's efficacy, the convenience of once-daily oral dosing, and its safety profile." He added, "We are actively considering implementing an Expanded Access Program (EAP) prior to commercialization to meet patient demand for continuous treatment."

He continued, "The AR1001 Phase 3 trial is expected to proceed to a New Drug Application (NDA) after the announcement of key top-line results in the first half of next year, with a target market launch in 2027. If the EAP is approved, it will accelerate patient access and contribute to accumulating real-world evidence."

Aribio is currently pursuing a merger with Kosdaq-listed company Solux, with the scheduled merger date set for January 20, 2026.

This content was produced with the assistance of AI translation services.