Aribio has completed global Phase 3 trials for its oral Alzheimer's treatment, AR1001. The company plans to commercialize the drug, aiming to lead the market for oral treatments in a sector currently dominated by intravenous therapies.
According to the Ministry of Food and Drug Safety, the number of clinical trial approvals for central nervous system (CNS) diseases rose to 67 last year, an increase of over 80% from 37 in 2021. With the aging population contributing to a steady rise in dementia cases, competition in CNS drug development is intensifying.
The global dementia treatment market is still in its early stages. Currently, intravenous formulations such as Eisai and Biogen's Leqembi (ingredient: lecanemab) and Eli Lilly's Donanemab (brand name: Keytruda) are leading the market. The need for long-term treatment for dementia highlights the challenges of dosing convenience.
On June 28, Aribio concluded the main Phase 3 trial (study name: POLARIS-AD) for AR1001, with the last patient receiving treatment after approximately three years and seven months of research. The large-scale trial involved 1,535 patients across 230 clinical sites in 13 countries, including the United States, with top-line results expected to be announced in September or October.
AR1001 is a low-molecular-weight oral treatment taken once daily, targeting multiple mechanisms, including improving cerebral blood flow, protecting nerve cells, and reducing brain inflammation and tau protein levels.
The company believes that the oral formulation will be competitive due to the long-term treatment nature of dementia. An Aribio representative stated, "Given the chronic nature of degenerative brain diseases that require long-term treatment, the convenience and sustainability of a once-daily oral medication are significant advantages."
Aribio also highlights that AR1001 is a low-molecular-weight compound that can be distributed at room temperature. The representative added, "AR1001's low-molecular-weight nature allows for room-temperature distribution, providing a competitive edge in accessing emerging markets in the Middle East, Latin America, Africa, and Asia, where Leqembi and Donanemab face structural entry barriers."
The company has established a commercial foundation, securing global licensing agreements for AR1001 related to Alzheimer's disease worth a total of 10 trillion won. In South Korea, the rights have been granted to Samjin Pharmaceutical, while in the Middle East, Latin America, and North Africa, the rights have been secured with UAE sovereign fund-backed Arcelor and China's Puxing Pharmaceutical. Rights for major markets in North America, Europe, and Japan have also been obtained.
Following AR1001, Aribio plans to advance the development of its next-generation CNS pipeline, including the Lewy body dementia treatment AR1005 and electronic drugs for brain diseases.
Meanwhile, Aribio is in the process of merging with LED lighting company Solux, with the merger date set for September 29. Solux announced on June 29 that it would change its name to Aribio Holdings, marking a significant shift towards a bio-centered business structure.
* This article has been translated by AI.
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