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
CFO Worx Named No. 448 on the 2026 Inc. 5000 List, the Most Prestigious Ranking of America’s Fastest-Growing Private Companies13.8.2026 23:21:00 EEST | Press release
CFO Worx today announced it has been ranked No. 448 on the 2026 Inc. 5000 list, the annual list of the fastest-growing private companies in America. The list is the most prestigious ranking of the nation’s most successful independent and entrepreneurial businesses, recognizing companies that have achieved remarkable growth while driving innovation, creating jobs, and shaping the future of the economy. Past honorees include companies such as Microsoft, Meta, Chobani, Oracle, and Patagonia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260813927944/en/ Brian Alvarez, CEO of CFO Worx "Earning a place on the list comes down to the trust our clients place in us and is a testament to the caliber of the team behind every engagement," said Brian Alvarez, CEO of CFO Worx. This year’s Inc. 5000 recognizes a new class of companies redefining what growth looks like. From AI and advanced manufacturing to healthcare, consumer products, a
BTG Pactual TIG and Conservation International Reach 20,000 Hectares of Cerrado Under Restoration, Accelerating Latin American Reforestation Strategy, Increasing Biodiversity and Social Impacts13.8.2026 18:47:00 EEST | Press release
BTG Pactual Timberland Investment Group (BTG Pactual TIG) and Conservation International today announced that native ecosystem restoration is now underway across more than 20,000 hectares of Brazil's Cerrado biome, marking a significant acceleration of the firms' Latin American reforestation strategy. According to data recorded by the Brazilian Restoration and Reforestation Observatory, an independent platform that tracks and maps native vegetation recovery, this further cements the strategy’s position as the largest ever restoration effort in the region. Conservation International serves as Impact Adviser for social and environmental outcomes. The strategy focuses on conserving, restoring and reforesting degraded landscapes across Latin America, including Brazil's Cerrado, one of the world’s most biodiverse and fastest disappearing seasonally dry ecosystems. More than half of the Cerrado has already been cleared for cattle ranching and farming. The strategy targets degraded cattle pas
Milliman names Jim Fulton next CEO13.8.2026 18:40:00 EEST | Press release
Milliman, Inc., a leading global actuarial and consulting firm, today announced that Jim Fulton has been named Milliman’s next Chief Executive Officer. Fulton has served as Milliman’s Chief Financial Officer since 2015 and has been a leader driving the firm’s organic growth and M&A strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811027168/en/ Milliman, Inc., a leading global actuarial and consulting firm, today announced that Jim Fulton has been named Milliman’s next Chief Executive Officer. Fulton has served as Milliman’s Chief Financial Officer since 2015 and has been a leader driving the firm’s organic growth and M&A strategy. Fulton’s appointment reflects Milliman’s evolution from an actuarial firm to a multidisciplinary consultancy, risk management, and technology solution provider. His expertise includes stints with Big 4 accounting and private equity-owned firms as well as technology startups. Fulton’s com
Clinilabs Announces Leadership Expansion and Welcomes Laura Shannon as Chief Executive Officer and Promotion of Founder Gary Zammit, Ph.D., to Executive Chairperson13.8.2026 17:05:00 EEST | Press release
Clinilabs, a leading specialty contract research organization (CRO) focused on central nervous system (CNS) drug and device development, today announced leadership expansion. Laura Shannon joins the organization as Chief Executive Officer as Gary Zammit, Ph.D., the Company’s founder, assumes the role of Executive Chairperson. This expansion of the senior leadership team is a recognition of a growing organization with global capabilities and continuing commitment to advancing treatments for patients with psychiatric and neurological disorders. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260813362140/en/ Laura Shannon joins Clinilabs as Chief Executive Officer as Gary Zammit, Ph.D., the Company’s founder, assumes the role of Executive Chairperson Ms. Shannon is a dynamic leader with more than 30 years of biopharma industry experience, known for her ability to build high-performing teams, forge strategic alliances, and drive
Resurgens Technology Partners Invests in Qarma to Advance the Future of Quality and Compliance13.8.2026 16:00:00 EEST | Press release
Resurgens Technology Partners (“Resurgens”), a software-focused private equity firm, today announced its partnership with Qarma, a leading global provider of AI-powered quality and compliance software for brands, retailers, and manufacturers managing complex, global supply chains. Qarma has built a platform that combines best-practice quality and compliance with hands-on execution where it matters most, on the factory floor. Qarma will continue to be led by its Co-founders, CEO Jacob Nedergaard and CTO Søren Mønsted. Founded in 2016, Qarma serves customers across industries, including furniture and home, apparel, consumer goods, and electronics. Its platform connects quality and compliance teams, sourcing professionals, suppliers, and inspectors. Over the past decade, Qarma has built one of the industry’s deepest operational quality platforms, combining best-practice workflows with software designed to work natively on factory floors worldwide. This unique operational foundation has ge
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