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
Biocytogen Announces FDA IND Clearance for Partner NEOK Bio’s NEOK002 Targeting Solid Tumors27.3.2026 02:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner NEOK Bio, Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for NEOK002, an EGFR/MUC1-targeting ADC program for solid tumors. NEOK Bio plans to initiate a Phase 1 clinical study in the second quarter of 2026 and expects to report initial data in 2027. This IND clearance marks an important milestone for NEOK002, an EGFR/MUC1-targeting ADC candidate developed by NEOK Bio and built on a bispecific antibody originally developed by Biocytogen and licensed in 2024. According to NEOK Bio, NEOK002 is being advanced for solid tumors and may offer differentiated efficacy and safety compared with monospecific ADC approaches directed at either target alone. Dr. Yuelei Sh
Spring is in Full Bloom at the Empire State Building with New Festive Experiences, Sweet Treats, and Seasonal Tower Lighting26.3.2026 22:30:00 EET | Press release
Spring is in full swing at the “World’s Most Famous Building.” The Empire State Building (ESB) today announced a vibrant lineup of spring events in NYC, which include special experiences, treat pop-ups, and an iconic tower lighting that captures the joy and color of the beautiful season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326216271/en/ Spring is in Full Bloom at the Empire State Building with New Festive Experiences, Sweet Treats, and Seasonal Tower Lighting “The Empire State Building Observation Deck has transformed into a celebration of the season and one of the best things to do in NYC this spring,” said Dan Rogoski, observatory general manager. “Whether it’s views beside our butterfly installation, sweet pop-ups, or a chance to spot the Easter Bunny, there is something special for every visitor.” Flutter of Color: The Empire State Building installed a brand-new photo opportunity on the 86th Floor Observati
Venture Global and Edison Announce Calcasieu Pass Arbitration Settlement26.3.2026 22:15:00 EET | Press release
Today, Venture Global and Edison jointly announced the signature of a commercial agreement for the settlement of the pending arbitration between the two companies concerning the Calcasieu Pass project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326559130/en/ Completion of the settlement is expected by the end of Q2 2026, at which point the arbitration will be terminated. The agreement fully resolves the arbitration in its entirety. As part of the settlement, Edison and Venture Global have also agreed to the delivery to Europe of additional cargoes beyond those envisaged under the long-term contract, to support gas supplies primarily to the Italian market. The first delivery is scheduled for May 2026, in Italy, at the Adriatic LNG Terminal. The agreement represents a significant step in strengthening commercial cooperation between the parties and it establishes a foundation for further future deliveries in the context
Reply Recognized as a Microsoft Frontier Partner for Enterprise AI Delivery26.3.2026 20:06:00 EET | Press release
Reply [EXM, STAR: REY] announces it has been recognized as a Microsoft Frontier Partner within the Microsoft AI Cloud Partner Program, earning the Frontier Partner Badge for demonstrating advanced capabilities in delivering AI-first solutions across Cloud & AI Platforms, AI Business Solutions, and Security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260326965586/en/ The recognition reflects Reply’s capabilities across the Microsoft ecosystem, built through the work of its specialized companies – including Aim Reply, Business Elements Reply, Cluster Reply, Root16 Reply, Solidsoft Reply, Valorem Reply, WM Reply and Zest Reply – supporting enterprise organizations in designing, implementing, and operating AI solutions on Microsoft platforms across real-world business scenarios. The Frontier Partner badge recognizes partners that demonstrate advanced AI driven capabilities and meet rigorous badge requirements at the time of
InterSystems nimittänyt terveydenhuoltotoiminnan johtajaksi tohtori Tim Ferrisin, entisen NHS- ja Mass General ‑johtajan26.3.2026 20:00:00 EET | Tiedote
InterSystems on luovien datateknologiaratkaisujen tarjoaja, jonka ratkaisuihin on tallennettu yli miljardi terveystietotietuetta maailmanlaajuisesti. Yritys ilmoitti tänään nimittäneensä terveydenhuoltotoiminnan johtajaksi lääketieteen tohtori Tim Ferrisin. Nimityksestä ilmoitettiin samaan aikaan, kun terveydenhuoltoalan johtajat kokoontuvat vuoden 2026 HIMSS Global Health Conference & Exhibition ‑tapahtumaan. Roolissaan Ferris pääsee soveltamaan kattavaa toimialakokemustaan, kun hän ohjaa yrityksen terveydenhuoltoratkaisujen kliinistä ja strategista suuntaa maailmanlaajuisesti. Laajan kokemuksensa turvin hän toimii maailmanlaajuisten terveydenhuoltojärjestelmien ja hallitusten strategisena neuvonantajana ja suunnittelee räätälöityjä teknologiaratkaisuja, jotka perustuvat todellisiin johtotason tarpeisiin. Samalla hän edistää akateemista tutkimustaan terveysdata-arkkitehtuurista sekä johtaa julkista keskustelua tekoälyn ja hoidon tarjoamisen yhdistämisestä. Ferris tuo InterSystemsiin a
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