AriBio Receives EMA Go-Ahead for Phase III Clinical Trial for Alzheimer’s

AriBio has achieved a crucial milestone in the development of its preclinical oral agent AR1001 with the recent authorization from the European Medicines Agency (EMA) for the Phase III clinical trial, known as POLARIS-AD (AR1001-ADP3-US01), aimed at treating early Alzheimer’s disease.

AriBio, headquartered in South Korea and with offices in the U.S., is a biopharmaceutical company dedicated to advancing innovative therapies for neurodegenerative diseases, notably Alzheimer’s disease.

This approval from the EMA adds to the previous authorizations granted by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), further solidifying the path forward for AR1001.

The final decision from the EMA greenlights the trial to commence across various member states, including Spain, the Netherlands, Italy, Germany, France, and the Czech Republic.

This worldwide trial is anticipated to enroll 1,150 participants across 200 sites, aiming to evaluate the efficacy and safety of AR1001, identified as a phosphodiesterase-5 (PDE5) inhibitor.

POLARIS-AD is designed as a double-blind registration trial controlled by placebo. It adopts the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as its main goal, a metric recognized and accepted by both the FDA and EMA.

James Rock, the chief clinical officer at AriBio, stated that the acceptance signifies the fourth region where participants will be systematically screened and enrolled, commencing from the second quarter of the year. He mentioned that the company has allocated considerable resources to promptly and effectively extend the Phase III program’s reach into these regions.

He added that the combination of robust interest in alternative treatment avenues for patients with Alzheimer’s disease, along with the growing global enthusiasm in AR1001, is something to be very excited about. Conducting this study on a global scale renders the asset highly appealing for worldwide accessibility if the efficacy and safety can be successfully validated, he added.

AR1001 is currently undergoing development as a prospective oral treatment for Alzheimer’s disease. Preclinical studies have showcased its neuroprotective properties, encompassing the inhibition of neuron apoptosis and the restoration of synaptic plasticity. These effects hold promise in potentially slowing the disease’s progression. The findings hint at AR1001’s potential disease-modifying effects, which could potentially decelerate the trajectory of Alzheimer’s disease.

This news comes around a month after AriBio finalized an agreement granting exclusive marketing rights for AR1001 in China. The undisclosed partner involved in the deal agreed to an upfront payment of $90 million. The deal included payments of up to $770 million for AriBio if certain objectives were to be achieved, including the royalty.

The company also received a Notice of Acceptance from MHRA in the U.K for AR1001 in late February, so the past few months have been very positive.