Biopharmaceutical company AriBio USA has enrolled the first participants in its Phase III registration trial of AR1001 in early Alzheimer’s Disease (AD) patients.
The double-blind, randomised, multi-centre, placebo-controlled AR1001-ADP3-US01 trial has been designed for assessing AR1001’s safety and efficacy in early AD patients over 52 weeks.
A total of 800 participants are planned to be enrolled, from nearly 75 sites, for 12 months of treatment that will be followed by an optional extension phase of two years.
In the trial, the participants will be randomised to receive either AR1001 30mg or a placebo once a day for 52 weeks.
All the participants who are originally assigned the placebo will be given AR1001 30mg for an additional two years in the optional-extension study.
The change in the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) at week 52 is the trial’s primary endpoint.
The company stated that the aim of the AR1001-ADP3-US01 trial is to evaluate the safety and efficacy of AR1001 in slowing the AD progression through different cognitive and functional tests.
AriBio USA chief medical officer Dr Greeley said: “As we learn more about Alzheimer’s disease, with the understanding that different therapeutic approaches are necessary to demonstrate a meaningful benefit to patients and their caregivers, we look forward to data on AR1001.
“As we understand more about Alzheimer’s disease, with the understanding that different therapeutics and lifestyle approaches will be necessary to demonstrate a meaningful benefit to patients and their caregivers, we expect AR1001 to be part of this treatment paradigm.”
The blood-brain barrier penetrating small molecule AR1001 is known for increasing neuroplasticity, promoting neurogenesis, inhibiting neuron apoptosis, and increasing the autophagy activity to remove toxic proteins.