Phase 3 clinical trial for investigational Alzheimer’s therapy expands to Asia, Europe

A South Korea-based life sciences company has announced expansion into the European Union, United Kingdom, Korea and China of its phase 3 study of an oral, investigational PDE5 inhibitor to treat early Alzheimer’s disease.

According to a release from AriBio, POLARIS-AD, a double-blind, randomized, placebo-controlled, multicenter study, will evaluate safety and efficacy of AR1001 (mirodenafil dihydrochloride) over 52 weeks.

In August, AriBio received investigational new drug approval from the Ministry of Food and Drug Safety in South Korea and submitted the clinical trial application (CTA) to the Center for Drug Evaluation under National Medicinal Products Administration the following month, per the release.

AriBio plans to submit the CTA to the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency in the U.K. by the end of 2023 with approvals expected in the first half of 2024.

“The POLARIS-AD global expansion plan not only helps facilitate recruitment and enrollment into the trial, but also allows the collection of efficacy and safety data as needed to justify new drug applications in these regions,” AriBio Chairman and CEO Matthew Choung said in the release. “This global trial by AriBio highlights the regulatory appetite for further research for Alzheimer’s disease and the need for alternative safe and oral therapies compared to the recently FDA approved monoclonal antibodies.”