South Korean clinical-stage biotech AriBio Co. has announced the filing for Phase III clinical trial approval in China for its anti-Alzheimer’s disease (AD) drug candidate, AR1001. The filing is currently under review by the National Medical Products Administration’s Center for Drug Evaluation.
Global Phase III Trial Expansion Plans
AriBio aims to assess AR1001 in 100-150 patients in China as part of its global Phase III Polaris-AD clinical trial, which is recruiting 1,250 participants worldwide. The Polaris-AD trial was initiated in the US in 2022, and AriBio is now preparing to seek approval to extend the trial to Europe alongside South Korea and China.
AR1001: A Selective PDE5 Inhibitor with Improved Brain Penetration
AR1001 is a selective inhibitor of phosphodiesterase 5 (PDE5), originally developed in South Korea as a treatment for erectile dysfunction. The drug is reported to be 10-fold more potent at inhibiting PDE5 and has improved brain penetration compared to approved PDE5 inhibitors, including sildenafil.
Scientific Rationale and Previous Trial Data
The use of PDE5 inhibitors in AD is supported by animal studies showing improved memory and learning due to increased levels of the intracellular messenger cGMP and potentially by improving blood supply to the brain. Several PDE5 inhibitors have also been reported to reduce amyloid production and lessen neuroinflammation and learning and memory deficits in mouse models for AD. AriBio previously presented data from a Phase II trial completed in 2021, where subgroup analysis showed improved ADAS-Cog13 scores for patients treated with AR1001, particularly for mild AD patients.-Fineline Info & Tech
