First participants enrolled in phase 3 trial for early AD therapeutic

AriBio USA Inc. announced the enrollment of the first participants in a phase 3 trial to evaluate the efficacy of a novel therapeutic to treat those with early Alzheimer’s disease.

According to a release from the company, the treatment candidate, AR1001, is a blood-brain barrier penetrating small molecule known to inhibit neuron apoptosis and promote neurogenesis, increase neuroplasticity and increase autophagy activity to remove toxic proteins.

The study is a randomized, placebo-controlled, double-blind, multicenter trial that is expected to enroll 800 participants from approximately 75 sites for 12 months of treatment, followed by an optional 2-year extension phase, the release stated.

Participants will be randomly assigned to receive either 30 mg of AR1001 or placebo once daily for 52 weeks. In the optional-extension study, those originally assigned to placebo will receive 30 mg of AR1001 for an additional 2 years of treatment. The primary endpoint in the trial is a change in the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) at week 52, according to the release.

“AriBio USA is excited to share this significant milestone, and we look forward to providing regular updates to the program as enrollment progresses in this phase 3 trial,” AriBio USA CEO James Rock said in the release. “We continue to engage with interested investigators and sites who are committed to making a difference in the treatment and care of patients with Alzheimer’s disease.”