AriBio has announced the receipt of a Notice of Acceptance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for its Phase III POLARIS-AD clinical trial of AR1001 for early Alzheimer’s disease (AD).

The development comes after the MHRA concluded its review on 21 February and provided a favourable ethical opinion.

The company anticipates initiating the trial before the end of the first quarter of this year in the country.

This randomised, double-blind, placebo-controlled, multicentre registration trial aims to evaluate the efficacy and safety of AR1001, a potential oral therapy for more than 52 weeks.

It will assess the impact of AR1001 on cognitive and functional decline in patients with early AD.

The study’s primary endpoint is the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB), which has been accepted by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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Secondary endpoints include the Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), and changes in plasma and cerebral spinal fluid (CSF) biomarkers.

To be eligible for enrolment, participants must have a confirmed diagnosis of early AD, as evidenced by amyloid presence.

A phosphodiesterase-5 (PDE5) inhibitor, AR1001 is being developed as a potential oral therapy for AD. It has demonstrated neuroprotective effects in pre-clinical studies.

These effects include inhibiting neuron apoptosis and restoring synaptic plasticity, which may potentially slow the progression of AD.

AriBio chief clinical officer James Rock said: “Acceptance of the POLARIS-AD clinical study in the UK is another achievement in the development of AR1001.

“This acceptance represents the third region that will be actively screening and enrolling participants in Q1’2024.

“As stated previously, AriBio will continue to expand the study into other regions where the regulatory and commercial markets are favourable for novel AD treatments.”