AR1001, a selective phosphodiesterase-5 (PDE5) inhibitor
AriBio will present the topline results of AR1001 against Alzheimer’s disease, titled ‘Results of a Phase 2 Study of AR1001 in Mild to Moderate Alzheimer’s Disease Patients’ on November 10th, at the 14th annual Clinical Trials on Alzheimer's Disease (CTAD) conference being held in Boston.
AR1001 is a highly selective and potent phosphodiesterase-5 (PDE5) inhibitor which is orally available and is able to cross the blood brain barrier (BBB), promoting the neuronal cell survival and inhibiting the accumulation of beta-amyloid in Alzheimer’s disease.
Pre-clinical studies with AR1001 have demonstrated anti-amyloid and anti-tau effects, along with neuroprotective effects by inhibiting neuronal apoptosis and restoring synaptic plasticity.
This clinical study was a randomized, placebo-controlled, double-blind, multi-center Phase 2 trial based in the U.S. that enrolled 210 patients for 26 weeks, followed by an optional additional 26 weeks of treatment. The patients were randomized to take either 10 or 30 mg of AR1001 or placebo once daily for 26 weeks and randomized to take either 10mg or 30mg of AR1001 once daily for the extension period. The co-primary endpoints were the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 13-item Version (ADAS-Cog 13) and the Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC).
AriBio, headquartered in Seongnam, South Korea, is a clinical-stage biotech-pharmaceutical company aimed at developing treatments for incurable diseases using its proprietary new drug development platform, named ‘ARID (Advanced, Rapid and Integrated Drug Development)’.
Meanwhile, the company is planning to initiate a global Phase 3 trial in 2022.
