Aribio's 'Oral Dementia Drug' Approved for Phase 3 Clinical Trial in the UK

Aribio announced on the 26th that it has officially received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the global Phase 3 clinical trial Polaris-AD of the oral Alzheimer's disease treatment AR1001.

Clinical Phase 3 Trial 'Polaris-AD' for Aribio's Dementia Treatment 'AR1001' Image
[Photo by Aribio]

Aribio is currently conducting the global Phase 3 clinical trial of AR1001 with a total of 1,250 patients, including 400 in the UK and seven European Union (EU) countries, 150 in Korea, 600 in the United States, and 100 in China. Clinical trial plans have already been approved in the US and Korea, and patient dosing has begun. In the UK, the trial is planned to start within the first quarter of this year. Clinical trial applications have also been submitted for Phase 3 in China and seven EU countries including France, Germany, Spain, Italy, Denmark, the Netherlands, and Czechoslovakia.

AR1001 aims to be an oral dementia treatment with multiple mechanisms of action. It is explained to have efficacy in inhibiting dementia progression and improving patients' memory and cognitive function through strong phosphodiesterase (PDE)-5 inhibitory activity. The mechanism can be broadly divided into three. First, it suppresses the intracellular production of amyloid-beta (Aβ) protein, which is considered one of the key factors in Alzheimer's dementia. While antibody therapies, which currently dominate dementia treatment, work by removing extracellular Aβ accumulated in the brain, AR1001, as a synthetic chemical drug, has a smaller molecular structure that allows it to penetrate cells and remove Aβ through autophagy, thereby inhibiting its accumulation.

Jaejun Jung, CEO of Aribio, said, “The approval of the Phase 3 clinical trial in the UK is an important milestone as it is the first time patients in Europe will take AR1001,” adding, “Polaris-AD is a truly global final clinical trial targeting the entire world in the field of dementia treatment.” David Greely, Chief Medical Officer (CMO) of Aribio’s US branch, also stated, “We have already received interest from many European researchers regarding the PDE-5 mechanism and inquiries about patient participation in the clinical trial,” and explained, “We will conduct the global Phase 3 clinical trial swiftly and successfully.”

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