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First Participants Enrolled in the AriBio USA Phase 3 Registration Trial to Evaluate AR1001 in Early Alzheimer’s Disease

AriBio USA, a clinical-stage biopharmaceutical company, announced the enrollment of their first participants in their Phase 3 trial to evaluate the efficacy of AR1001 in participants with early Alzheimer’s Disease (AD). 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.

This study is a randomized, placebo-controlled, double-blind, multi-center Phase 3 trial that plans to enroll 800 participants from approximately 75 sites for 12 months of treatment, followed by an optional two-year extension phase. Patients will be randomly assigned to receive either 30 mg of AR1001 or placebo once daily for 52 weeks. In the optional-extension study, participants originally assigned to placebo will receive 30 mg of AR1001 for an additional two years of treatment. The primary endpoint in the trial is the Change in the Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) at Week 52. “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,” said Dr. Greeley, CMO for AriBio USA.

“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. 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,” said James Rock, CEO of AriBio USA, Inc. Enrollment is expected to require approximately 2 years for this Phase 3 trial. Dr. Greeley stated, “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.”

AriBio Ltd, the parent company of AriBio USA, is committed to developing new therapeutics in the neurology space with a pipeline of PDE-5 inhibitors and other new molecular entities. “Our goal is to transform the treatment options available for patients with dementia to improve their daily lives,” stated Dr. Matthew Choung, CEO of AriBio Ltd.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer's disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov.

About AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with a focus on the development of therapies for neurodegenerative diseases. AriBio USA, INC. is the subsidiary company of AriBio Co., Ltd. based in San Diego, CA in charge of clinical operations and regulatory affairs for AriBio.

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