Aribio has completed the global Phase 3 clinical trials for its oral Alzheimer's treatment candidate, AR1001. According to the company, the main POLARIS-AD Phase 3 trial officially concluded on June 28 with the last patient receiving treatment.
The Phase 3 trial for AR1001 began in December 2022 at a clinical site in Washington State, USA, and expanded to 230 clinical centers across 13 countries, including South Korea, the United States, Canada, Europe, and China. A total of 1,535 patients with early-stage Alzheimer's disease were enrolled, with 1,348 completing the 52-week main treatment.
The number of enrolled patients by country includes 658 from the U.S. and Canada, 551 from the UK and eight EU countries, 200 from South Korea, and 126 from China. The company reported a dropout rate of just 12.2% in this long-term Alzheimer's trial, with 95.5% of patients who completed treatment participating in a one-year extension study.
An Aribio representative stated, "The high willingness of patients and medical staff to participate in the trial and their adherence to the treatment are encouraging indicators. Long-term treatment data will strengthen the evidence for safety and efficacy." The extension study is expected to conclude by the end of June 2027.
AR1001 is a low-molecular-weight compound that can be taken orally, distinguishing it from existing antibody therapies. The company emphasizes its multi-target approach to addressing the complex pathophysiology of Alzheimer's disease, including improving cerebral blood flow, protecting nerve cells, and reducing brain inflammation and tau hyperphosphorylation.
Aribio plans to expand the indications for AR1001 and develop additional treatments, including the multi-target Lewy body dementia drug AR1005 and next-generation electronic therapies for brain diseases. The company is also pursuing a vaccine for degenerative brain diseases and immune-based treatment strategies linked to its Aribio Lab's immune enhancement platform.
Following the completion of the Phase 3 trials, Aribio will begin data cleaning, database locking, and statistical analysis. The company plans to release topline data containing key clinical results between late September and October.
Jae-jun Jeong, CEO of Aribio, emphasized, "We will demonstrate the potential of a global blockbuster drug developed in South Korea through the topline data."
In related news, Aribio previously secured global licensing agreements worth a total of 10 trillion won for AR1001. The company has signed a contract worth 100 billion won with Samjin Pharmaceutical and agreements with Arsera, a pharmaceutical company under the UAE sovereign wealth fund, for 1.24 trillion won in the Middle East, South America, and North Africa, as well as with Puxing Pharmaceutical in China for 1.02 trillion won in the Greater China region, and 630 billion won in the ASEAN region, along with contracts totaling 7 trillion won in major markets such as North America, Europe, and Japan.
According to a GlobalData report, the number of dementia patients in South Korea is estimated to reach 920,000 by 2024. The global dementia treatment market is projected to grow from 48 trillion won in 2023 to approximately 31 trillion won by 2033, with an annual growth rate of 20%.
The Phase 3 trial for AR1001 began in December 2022 at a clinical site in Washington State, USA, and expanded to 230 clinical centers across 13 countries, including South Korea, the United States, Canada, Europe, and China. A total of 1,535 patients with early-stage Alzheimer's disease were enrolled, with 1,348 completing the 52-week main treatment.
The number of enrolled patients by country includes 658 from the U.S. and Canada, 551 from the UK and eight EU countries, 200 from South Korea, and 126 from China. The company reported a dropout rate of just 12.2% in this long-term Alzheimer's trial, with 95.5% of patients who completed treatment participating in a one-year extension study.
An Aribio representative stated, "The high willingness of patients and medical staff to participate in the trial and their adherence to the treatment are encouraging indicators. Long-term treatment data will strengthen the evidence for safety and efficacy." The extension study is expected to conclude by the end of June 2027.
AR1001 is a low-molecular-weight compound that can be taken orally, distinguishing it from existing antibody therapies. The company emphasizes its multi-target approach to addressing the complex pathophysiology of Alzheimer's disease, including improving cerebral blood flow, protecting nerve cells, and reducing brain inflammation and tau hyperphosphorylation.
Aribio plans to expand the indications for AR1001 and develop additional treatments, including the multi-target Lewy body dementia drug AR1005 and next-generation electronic therapies for brain diseases. The company is also pursuing a vaccine for degenerative brain diseases and immune-based treatment strategies linked to its Aribio Lab's immune enhancement platform.
Following the completion of the Phase 3 trials, Aribio will begin data cleaning, database locking, and statistical analysis. The company plans to release topline data containing key clinical results between late September and October.
Jae-jun Jeong, CEO of Aribio, emphasized, "We will demonstrate the potential of a global blockbuster drug developed in South Korea through the topline data."
In related news, Aribio previously secured global licensing agreements worth a total of 10 trillion won for AR1001. The company has signed a contract worth 100 billion won with Samjin Pharmaceutical and agreements with Arsera, a pharmaceutical company under the UAE sovereign wealth fund, for 1.24 trillion won in the Middle East, South America, and North Africa, as well as with Puxing Pharmaceutical in China for 1.02 trillion won in the Greater China region, and 630 billion won in the ASEAN region, along with contracts totaling 7 trillion won in major markets such as North America, Europe, and Japan.
According to a GlobalData report, the number of dementia patients in South Korea is estimated to reach 920,000 by 2024. The global dementia treatment market is projected to grow from 48 trillion won in 2023 to approximately 31 trillion won by 2033, with an annual growth rate of 20%.
* This article has been translated by AI.
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