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)
31.3.2023 19:00:00 EEST | Business Wire | Press release
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
Bregal Milestone III Closes at its Increased Hard Cap of €915 Million7.7.2026 14:00:00 EEST | Press release
Bregal Milestone (“Milestone” or the “Firm”), a leading European software private equity firm, today announced the final close of its third fund, Bregal Milestone III (“Fund III” or the “Fund”), at its increased hard cap of €915 million. The Fund was oversubscribed and marks a significant broadening of the Firm’s global investor base. Completed in eight months from first close and achieved against a challenging fundraising environment, the result reflects the strength of Milestone’s AI-centric approach and demonstrable track record. Jan Bruennler, Philippe Lautenberg and Cyrus Shey, Co-Founders and Managing Partners at Bregal Milestone, commented: “Bregal Milestone III reflects strong conviction in our approach to investing in mission-critical European software, AI and cybersecurity businesses and helping them scale. We are thankful for the support and confidence shown by our limited partners, both longstanding and new, and remain focused on executing the strategy that has defined Mile
HTEC and Embotech Partner to Scale Deployment of Autonomous Driving Solutions for Industrial Logistics7.7.2026 13:39:00 EEST | Press release
HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707870943/en/ HTEC, a global technology and AI engineering company headquartered in Silicon Valley, and Embotech, a global leader in safety-certified Level 4 autonomous driving solutions for industrial logistics, today announced a strategic partnership to scale deployment of Embotech's autonomous driving solutions across vehicle platforms, customer programmes and industrial sites. The partnership comes as Embotech’s proven autonomous driving solutions are being adopted across a growing number of vehicle platforms
Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile7.7.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the 26-week results (Part B) from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which confirm COMP360’s rapid onset and durable profile. The 26-week findings in nearly 600 patients build on previously reported results from the first Phase 3 trial, COMP005, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD. The COMP360 Phase 3 program participants represent a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within the context of this severe population, 39% of participants in the 25 mg arm achieved a clinically m
Private Department of Sheikh Mohammed bin Khalid Al Nahyan Invests in MidOcean Energy and Forms Strategic Partnership with EIG7.7.2026 13:16:00 EEST | Press release
The Private Department of Sheikh Mohammed bin Khalid Al Nahyan (the “Private Department”) has today committed to invest $1.13bn in MidOcean Energy (“MidOcean” or the “Company”), a liquefied natural gas (LNG) company formed and managed by EIG. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707259928/en/ In parallel with the investment, the Private Department and EIG have established a strategic partnership focused on capital aggregation, investment origination, and the development of institutional investment opportunities across the United Arab Emirates and selected regional markets. The Investment in MidOcean represents the Private Department’s entry into the global LNG sector and marks the launch of a broader strategic relationship with EIG, a global energy and infrastructure investment firm. Through this partnership, the parties intend to collaborate on future investment opportunities across the energy and related infra
Infobip Research Reveals Businesses Scaling AI-Powered Defenses to Counter Surge in Automated Fraud7.7.2026 12:55:00 EEST | Press release
New research from global AI-first cloud communications platform Infobip reveals a growing surge in AI-powered fraud and enterprise defenses. Analyzing billions of interactions globally, Infobip’s 2026 Fraud & Security Report highlights a year of dramatic contrasts. There have been record volumes of blocked fraudulent traffic alongside the rapid scaling of intelligent, AI-powered defenses. The report reveals that while fraudsters are using AI to scale and personalize harmful messaging, leading to a 77% increase in detected threats, businesses are responding in kind. Adoption of AI-powered fraud detection grew by 71% year-on-year, while pattern-based detection increased by 105%, underscoring a shift toward adaptive security. The report demonstrates the impact of AI-first security. Leading UK-based clothing brand NEXT is leveraging Infobip Signals, an AI and machine learning-powered solution designed to combat artificially inflated traffic, helping protect customers against fraud. Raz Raz
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