First Participants Enrolled in the AriBio USA Phase 3 Registration Trial to Evaluate AR1001 in Early Alzheimer’s Disease
5.1.2023 15:09:00 EET | Business Wire | Press release
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230105005102/en/
Contact information
Fred Kim
fredkim@aribiousa.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Follow-on Order Brings Orders from INNIO Data Center Customer to 1.72 GW, Further Strengthening INNIO’s Data Center Backlog and Revenue Visibility22.10.2026 15:30:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) today announced a 620 megawatt (MW) follow-on order from a leading developer and operator of mega-scale data center campuses in the U.S. Together with the customer’s 1.1 gigawatt (GW) order announced in July 2026, the new order brings cumulative orders from the customer to approximately 1.72 GW, further strengthening INNIO’s order backlog and visibility into future revenues. “This follow-on order, coming just months after the customer’s initial 1.1 GW order, underscores the strength of customer demand and continued confidence in INNIO. Our containerized Jenbacher solutions deliver what data centers need most: fast deployment, high power density, fuel efficiency, and the performance to support demanding AI workloads,” said Dr. Olaf Berlien, President and CEO of INNIO. “Repeat orders of this scale, combined with long-term service agreements, strengthen our backlog and expand the services base that underpins our business model,” added Dr. Berlien. All 620 MW will
European Public Transport Budgets Require 36% Annual Spending Increase by 2035, Arthur D. Little and Polis Research Finds22.10.2026 15:30:00 EEST | Press release
Europe’s public transport sector currently accounts for €130 billion in annual expenditure, yet faces a growing funding gap as demand rises and environmental and resilience requirements intensify. New research from Arthur D. Little (ADL)’s Future of Mobility Lab and POLIS, a network of European cities and regions collaborating to develop innovative and sustainable urban transport solutions, outlines the scale of this financial shortfall and provides radical recommendations for overcoming it. Based on research with senior transport and policymakers, in-depth literature reviews, and real-world data from Paris, London, Amsterdam, Berlin and New York, the report estimates that additional spending will require a 36% increase in overall annual expenditure from now to 2035 onwards. This is made up of a 13% rise in operating expenditure (OPEX) and 56% in capital expenditure (CAPEX), driven by: Hidden debt caused by historic underinvestment in existing infrastructure (6% of additional funding n
Hitachi Report Examines Readiness for Physical AI in Industrial Companies22.10.2026 15:00:00 EEST | Press release
Hitachi, Ltd. (TSE:6501, "Hitachi") announced the release of its physical AI survey-based research report, Beyond the Pilot: Industry’s Physical AI Progression. The company surveyed over 200 global decision-makers from organizations operating in mission-critical industrial sectors including energy, manufacturing, transportation and logistics. The report explores how businesses today adopt AI in industrial use-cases, where they see the greatest value, and what it will take to scale toward physical AI deployments. Readers will gain practical insights on how to accelerate AI adoption while improving competitiveness, productivity, and long-term business performance. After successfully transforming knowledge work, AI is now entering the physical systems that form society’s backbone: energy, industrial, and mobility infrastructure, to name a few. Given these systems’ reliability, safety, and regulatory requirements, there is no room for AI hallucinations. In short, AI technology applied to t
Datavault AI Signs Non-Binding Letter of Intent to Acquire a 19.9% Equity Stake in DataMEDS AI in Consideration of an Expanded Technology License22.10.2026 15:00:00 EEST | Press release
Datavault AI Inc. (“Datavault AI” or the “Company”) (Nasdaq: DVLT), an Artificial Intelligence Platform (“AIP”) company providing data monetization, credentialing, and real-world asset (“RWA”) tokenization, today announced that it has entered into a non-binding letter of intent (“LOI”) to acquire a 19.9% equity interest in DataMEDS AI, Inc. (NASDAQ: MEDS) (“DataMEDS”) in consideration of an expansion of its existing technology license with DataMEDS. The proposed transaction is subject to completion of due diligence and negotiation of definitive agreements and will be subject to customary closing conditions for a transaction of this nature. The proposed transaction is structured to provide Datavault AI with the opportunity to obtain an equity interest in DataMEDS while preserving ownership of its underlying intellectual property. In exchange for expanding its existing technology license, Datavault AI expects to receive a 19.9% equity interest in DataMEDS on a fully diluted basis, with t
Megaport Expands AWS Connectivity With AWS Interconnect to Simplify How Customers Connect Their Infrastructure22.10.2026 15:00:00 EEST | Press release
Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced support for AWS Interconnect, a new managed connection model from Amazon Web Services (AWS) designed to simplify how businesses connect their infrastructure to AWS. AWS Interconnect from Megaport gives enterprises and AI infrastructure providers an automated connectivity option as their requirements grow beyond traditional AWS Hosted Connections. MACsec encryption and four redundant links across two sites will be included as part of the service at general availability, with customers able to select connection speeds from 1 Gbps to 100 Gbps. Customers can start an order for AWS Interconnect - last mile from either the Megaport Portal or AWS Management Console and complete it from the other. AWS and Megaport then automate the underlying network configuration, including VLANs, IP subnets, MTU, and BGP. This removes the need for customers to arrange the port, letter of authorizatio
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom