AriBio Co., Ltd. to Present Biomarker Data for AR1001 from the Mild to Moderate Alzheimer’s Disease Phase 2 Study at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2023)
AriBio Co., Ltd. announced that David Greeley MD, Chief Medical Officer at AriBio, will present biomarker data from the completed phase 2 study in patients with mild to moderate Alzheimer’s disease who were treated with 10mg and 30mg of AR1001. AR1001 is a potent PDE5 inhibitor with preliminary efficacy in cognition, and preclinical effects on neuron apoptosis inhibition, promotion of neurogenesis, increase in neuroplasticity, and stimulation of autophagy to remove toxic proteins.
The phase 2 study was a double-blind, randomized, placebo-controlled, multi-center trial to evaluate the safety and preliminary efficacy of AR1001 over 26 and 52 weeks of treatment in patients with mild to moderate Alzheimer’s disease. The trial enrolled 210 patients at 21 research centers in the United States.
Plasma collected from patients at baseline, week 26 and week 52 was analyzed by Quantarix using the Simoa HD-X analyzer. Meaningful, statistically significant changes were found over 52 weeks of treatment in a post-hoc analysis, including a dose dependent decline of pTau181 at 26 weeks, and further declines after 52 weeks of treatment. Patients randomized to 10 and 30 mg AR1001 treatment after 26 weeks of treatment with placebo also demonstrated similar declines in pTau181. Other plasma markers including NfL, GFAP and AB42/40 ratio were also measured but showed minimal change or no statistical differences over baseline levels.
AriBio initiated a phase 3 pivotal trial with 30mg of AR1001 to be administered daily to early and mild Alzheimer’s disease patients in December of 2022. Enrollment is expected to continue through 2024. “This biomarker data helps bolster the positive effects seen in cognition with the high dose of AR1001 in the Phase 2 study in mild AD patients. We will continue to collect both CSF and plasma as part of the phase 3 study to analyze as supportive data,” stated Dr. Greeley.
About AR1001-ADP3-US01
AR1001-ADP3-US01 (NCT05531526) is a 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 offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. The company continues to expand its partnerships to accelerate best-in-class treatment options and further advancements in the field of medicine.
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/20230331005009/en/
Contact information
James Rock jimrock@aribiousa.com
AriBio USA Branch
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
Klarna Launches Tap to Pay for In-Store Purchases Across 14 Markets2.12.2025 10:00:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, today launches the brand new feature Tap to Pay across 14 European markets, bringing flexible payments into physical retail at scale and transforming the Klarna app into an everyday contactless wallet. With more than 80% of European shopping still happening in physical stores, Tap to Pay brings consumers the ease of online shopping into the bricks and mortar stores. Instead of hunting for cards or juggling apps, everything sits in one place — the Klarna app — making every purchase smoother from start to finish. Utilising NFC technology, Tap to Pay turns the Klarna app into a contactless wallet, letting consumers set up a flexible payment plan and pay with a tap, all in one place – without adding their card to another wallet or switching apps at checkout. Tap to Pay builds on the rapid global uptake of the new debit-first Klarna Card, now used by more than 4 million consumers. The card is debit by default, with the option t
SkillOnNet Redefines RNG Gaming with World-First Launch of AI-Powered GAIA Roulette2.12.2025 10:00:00 EET | Press release
Global entertainment brand SkillOnNet has announced the launch of GAIA Roulette, a groundbreaking new roulette experience powered by artificial intelligence. The game – which is now live on PlayUZU Mexico, with plans to expand to additional markets across the SkillOnNet network in the coming months – blends the thrill of RNG gameplay with the 3D realism of a live dealer. It’s the world’s first AI-driven roulette host now in commercial use. Unlike traditional RNG tables, GAIA Roulette features an intelligent, interactive digital dealer that is personalized to each player. GAIA learns player preferences, adapts its communication style, and provides real-time assistance, helping users understand bets, game flow, and strategies. Players can discuss game events – asking questions about game results, previous numbers, their wins and losses, and review gameplay history – but they can also talk about everyday topics like hobbies, sports, foods, movies, weather and more to make the experience m
Expedition Growth Capital Raises $375 Million Fund III in First and Final Close2.12.2025 10:00:00 EET | Press release
Expedition Growth Capital (“Expedition”), a software-specialist growth equity firm, today announced that it has raised its third fund of $375 million, continuing its focus on partnering with rapidly growing companies from across Europe that have built high-quality products and customer bases, without venture capital. The oversubscribed raise was completed in four months, with more than half of commitments from US investors, including leading endowments and foundations. Since its founding in late 2020, Expedition has built a portfolio of 17 bootstrapped software leaders from nine European countries, the majority already operating in North America. Portfolio companies include Dougs, a Lyon-based AI-powered accounting solution used by over 30,000 businesses, epilot, a Cologne-based vertical AI solution driving digital workflows in the energy and utilities industry, Factbird, a Copenhagen-based software platform improving production efficiency at some of the world’s largest manufacturers,
Payments Modernisation: Gap Between Confidence and Readiness Among Industry Leaders Widens, ACI Worldwide Study Finds2.12.2025 09:00:00 EET | Press release
Payments leaders remain confident about the pace of industry innovation, but many risk falling behind as expectations accelerate. New global research from ACI Worldwide (NASDAQ: ACIW) and Globant reveals a widening gap between confidence and readiness that could define industry leadership in 2026 and beyond. The report Payments in Transition: Leadership in an era of transformation, based on a survey of 500 industry leaders across North America, Europe, Latin America, Middle East & Africa, and Asia Pacific, shows that while 69% of executives consider their organisations to be payments leaders, fewer than half (44%) say payments innovation is a C-suite priority. This disconnect is driven by barriers that will become increasingly costly in the year ahead. More than half (55%) of executives admit they are not fully using the technology already available, and 44% cite legacy platforms as the biggest obstacle to innovation. Internal resistance compounds the challenge, with 53% pointing to cu
Pre-filled Syringe Presentation of BYOOVIZ®, Samsung Bioepis' Biosimilar to Lucentis (Ranibizumab), Gains European Approval2.12.2025 08:00:00 EET | Press release
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ® pre-filled syringe (PFS), a biosimilar referencing Lucentis1 (ranibizumab). BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). The PFS presentation is regarded as the standard of care in ophthalmology, providing convenience for administration with precise dosing and ease of use with syringe injection, as well as safety benefits in the form of a decreased risk of endophthalmitis versus v
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