CA-ARIBIO-CO.,-LTD.
31.3.2023 18:01:37 CEST | 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/
About Business Wire
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
PMCOrganometallix Announces Price Increase on All Products24.4.2026 22:55:00 CEST | Press release
Due to significant changes in market conditions, PMC Organometallix, Inc. announces that effective May 1, 2026, or as contracts permit, prices across all product lines globally will increase by 10-25%. This adjustment is driven by sustained cost pressures from key inputs including rising raw material costs and escalating freight and logistics expenses. While the company has been absorbing these increases, the current economic environment brought on by the geopolitical crisis of the Iran conflict requires this adjustment to continue providing the high-quality, consistent materials and supply reliability that customers expect. PMC Organometallix will implement these changes in a transparent, collaborative manner and values your partnership while navigating these economic challenges. Customers with questions or to discuss a specific situation should contact their account representative. About PMC Group PMC Group is a growth-oriented, diversified, global chemicals and plastics company deli
Frankfurt Higher Regional Court upholds BESREMi® arbitral award in favor of AOP Health24.4.2026 18:52:00 CEST | Press release
Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424005227/en/ Portrait Dr. Rudolf Widmann, Founder AOP Health Credit: AOP Health/Daniel Ospelt Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.” The Product in Dispute The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into
Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher24.4.2026 16:37:00 CEST | Press release
Compass is the most advanced company in classic psychedelics and has generated positive data from two ongoing large, well controlled Phase 3 clinical trials, designed to uphold the highest regulatory standardsFDA grants Compass NDA rolling submission and review request, based on Phase 3 dataCNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin, for treatment-resistant depression (TRD)CNPV further accelerates momentum and Compass is confident and ready to deliver for patients Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be en
Banma Intelligence and Alipay Launch AI Cockpit Solution Powered by Alipay AI Pay, Enabling Seamless and Secure In-Car Transactions by Voice24.4.2026 16:04:00 CEST | Press release
At the 2026 Beijing International Automotive Exhibition (“Auto China 2026”), OS and AI technology company Banma Intelligence and Alipay today launched a new AI cockpit solution integrating Alipay AI Pay, enabling drivers to complete purchases by voice command directly from their vehicle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424618328/en/ Industry-first AI Cockpit Solution with Alipay AI Pay Unveiled “In the past two years, smart cockpits have achieved rapid advances in perception and decision-making,” said Ming Cai, Banma Intelligence Chief Product Officer. “With large models onboard, vehicles can understand user intent and make recommendations. By integrating Alipay AI Pay into our AI cockpit solution, we are removing the last friction point in the in-car smart cockpit experience - drivers simply speak to pay, no phone required.” The new AI cockpit solution initially covers two high-frequency use cases: enterta
Spatial Announces the Release 2026 1.0.1: New Enhancements Across 3D InterOp, Data Prep, Meshing, and 3D Modeling SDKs24.4.2026 15:21:00 CEST | Press release
Spatial Corp., the leading software development kit provider for design, manufacturing and engineering solutions and a subsidiary of Dassault Systèmes, today announced new enhancements across several of its product lines. These updates further strengthen Spatial’s commitment to delivering high-performance solutions that optimize interoperability, data preparation, and advanced modeling workflows. Designed to improve efficiency and robustness across CAD translation, modeling, meshing, and simulation processes, the latest updates introduce expanded format support, enhanced PMI handling, and new capabilities for complex geometry processing. 3D InterOp NX Reader Enhancement for 2D Drawings The NX reader imports 2D drawings as visualization data from NX 2412 and later versions. glTF Writer Supports Draco Compression glTF export incorporates Draco compression for meshes and point-clouds to significantly reduce output file sizes. Enhanced Support for Reading Product Manufacturing Information
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