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
Adtran and GLDS expand partnership to deliver billing-driven, zero-touch automation for subscriber lifecycle management21.4.2026 21:00:00 EEST | Press release
Adtran today announced a new phase in its long-standing partnership with GLDS, delivering billing-driven, zero-touch automation for subscriber lifecycle management. As broadband and managed Wi-Fi services scale, manual hand-offs between billing, OSS and in-home networking systems are no longer sustainable. By enabling GLDS BroadHub® to orchestrate subscriber creation, service activation and ongoing lifecycle changes across access and the connected home, the solution streamlines operations, accelerates time to revenue and reduces operational complexity. This approach gives broadband providers greater control as subscriber expectations rise and service models evolve. “Our partnership with Adtran is built around a shared goal: making it easier for broadband operators to serve a growing and increasingly demanding customer base,” said Garrick Russell, president and COO of GLDS. “By extending BroadHub® billing-driven automation all the way through to in-home Wi-Fi, we’re taking the pain out
Adtran and GLDS expand partnership to deliver billing-driven, zero-touch automation for subscriber lifecycle management21.4.2026 21:00:00 EEST | Press release
Adtran today announced a new phase in its long-standing partnership with GLDS, delivering billing-driven, zero-touch automation for subscriber lifecycle management. As broadband and managed Wi-Fi services scale, manual hand-offs between billing, OSS and in-home networking systems are no longer sustainable. By enabling GLDS BroadHub® to orchestrate subscriber creation, service activation and ongoing lifecycle changes across access and the connected home, the solution streamlines operations, accelerates time to revenue and reduces operational complexity. This approach gives broadband providers greater control as subscriber expectations rise and service models evolve. “Our partnership with Adtran is built around a shared goal: making it easier for broadband operators to serve a growing and increasingly demanding customer base,” said Garrick Russell, president and COO of GLDS. “By extending BroadHub® billing-driven automation all the way through to in-home Wi-Fi, we’re taking the pain out
Unleashing GEN4: a New Era of High-performance, Sustainable Electric Racing Begins21.4.2026 18:54:00 EEST | Press release
The Fédération Internationale de l'Automobile (FIA) and Formula E have unleashed the GEN4 car on track in its debut run in the South of France, signalling the beginning of a new era for electric motor sport. This all-new car will be raced in the 2026/27 Season of the ABB FIA Formula E World Championship. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421618886/en/ Unleashing GEN4: A new era of high-performance, sustainable electric racing begins Capable of speeds over 335kph (208mph), 0-100kph in approximately 1.8s, and 0-200kph in just 4.4s - 1.5s faster than its predecessor. GEN4 produces up to 600kW of power, a 71% increase in base output over GEN3 Evo, and is also the only single-seater with permanent all-wheel drive, promising to deliver the fastest-ever lap times by a Formula E car. As the only all-electric FIA World Championship, GEN4 is both at the pinnacle of motor sport innovation and a testbed for future mobili
Unleashing GEN4: a New Era of High-performance, Sustainable Electric Racing Begins21.4.2026 18:54:00 EEST | Press release
The Fédération Internationale de l'Automobile (FIA) and Formula E have unleashed the GEN4 car on track in its debut run in the South of France, signalling the beginning of a new era for electric motor sport. This all-new car will be raced in the 2026/27 Season of the ABB FIA Formula E World Championship. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421618886/en/ Unleashing GEN4: A new era of high-performance, sustainable electric racing begins Capable of speeds over 335kph (208mph), 0-100kph in approximately 1.8s, and 0-200kph in just 4.4s - 1.5s faster than its predecessor. GEN4 produces up to 600kW of power, a 71% increase in base output over GEN3 Evo, and is also the only single-seater with permanent all-wheel drive, promising to deliver the fastest-ever lap times by a Formula E car. As the only all-electric FIA World Championship, GEN4 is both at the pinnacle of motor sport innovation and a testbed for future mobili
Resale on the Rise: Klarna's Resell Feature Grows 75% as Consumers Put Real Money Back in Their Pockets21.4.2026 18:00:00 EEST | Press release
New data from Klarna,the global digital bank and flexible payments provider, reveals that its in-app resell feature is gaining significant momentum:listings created through the app grew by up to 75% over the past 13 months*, as consumers increasingly turn to resale as a way to earn real money from items they already own. The data points to a broader shift in financial behaviour: consumers are increasingly treating the things they own not as fixed costs, but as assets with ongoing value. Reselling is becoming routine, not a one-off First launched in Sweden in 2022, Klarna's resell feature is now available across 15 markets, letting users list items for resale directly from their purchase history via leading resale marketplaces such as eBay, Poshmark and Tradera. No need to remember what they paid, find the receipt, or switch to another app. Klarna pre-fills key listing details, making the process as frictionless as possible. It is a convenience that is clearly resonating: returning user
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