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
FuzeBox AI Named Founding Co-Author of SPUR Coalition Technical Committee on Verifying AI Content Use5.10.2026 16:00:00 EEST | Press release
FuzeBox AI has been named by the SPUR Coalition, an international nonprofit of 37 news and media organizations, as one of four founding co-authors of its Evidence Profile Technical Committee, adopted Sept. 2, 2026, to draft an evidence profile for SPUR's Content Telemetry standard: a way for publishers to verify AI usage reports without depending on the reporting company's cooperation. Under SPUR's current standard, AI companies self-report their content use. A company that skips reporting leaves no record, and publishers can't check what they do receive. On July 10, 2026, FuzeBox proposed its Verified Provenance Telemetry Standard (VPTS): publishers seed content with detectable markers, then verify their appearance in AI outputs via an auditable ledger, with no change to SPUR's standard. Within 48 hours, three organizations filed related proposals: ProRata on usage magnitude, Encypher CEO Erik Svilich on the verification question FuzeBox raised, and LicenseFoundry on portable proof of
Mary Kay Introduces the K-Beauty Texture Edit5.10.2026 15:02:00 EEST | Press release
Mary Kay Inc.,the iconic beauty giant announced today the launch of the K-Beauty Texture Edit, aspecial-edition skin care collection available while supplies last. The collection builds on the momentum of the company's largest consumer-facing global brand platform, Beauty Is More Beautiful Shared™ which launched in September. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005600130/en/ Mary Kay's Special Edition K-Beauty Texture Edit is a trend-forward collection which includes three Korea-made products: the Mary Kay® Melt-In Cleansing Balm, Mary Kay® Snail Gel Face Patches and Mary Kay® Collagen Moisturizing Gel. (Image Credit: Mary Kay Inc.) Inspired by Korea's globally influential skin care and self-care philosophy designed to bring playful textures, innovative ingredients, and elevated beauty experiences, the K-Beauty Texture Editwas designed to resonate with a global cultural beauty movement captivating the next gene
GE HealthCare to Acquire SOFIE Biosciences, Establishing a 'Final Mile' Footprint for PET Radiopharmaceutical Supply in the U.S.5.10.2026 15:00:00 EEST | Press release
GE HealthCare (Nasdaq: GEHC) today announced a definitive agreement to acquire SOFIE Biosciences, a leading U.S.-based CMO for PET radiopharmaceuticals, from Trilantic North America, for a purchase price of $945 million paid in cash. The transaction is expected to close in the first half of 2027, subject to closing conditions, including regulatory approvals, at which time SOFIE Biosciences will become part of GE HealthCare’s PDx segment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005273717/en/ SOFIE Biosciences has 15 CMO sites across the U.S., manufacturing PET radiopharmaceutical products The acquisition of SOFIE Biosciences establishes a footprint for GE HealthCare in the time-critical ‘final mile’ of U.S. PET radiopharmaceutical supply, while also enabling PDx to participate in other high growth areas outside its own product portfolio. With a U.S. network of 15 CMO sites operating 21 cyclotrons, and a theranostics
Henkell Freixenet Strengthens Premium Dealcoholized Sparkling Wine Production with Solos' Patented Aroma Recovery System5.10.2026 14:24:00 EEST | Press release
Henkell Freixenet is expanding its premium dealcoholized sparkling wine production capabilities through the deployment of Solos Technology's patented Aroma Recovery System (ARS) at its Wiesbaden production site, the Group’s expertise centre for alcohol-free production. The installation represents a significant investment in next-generation dealcoholized sparkling wine production, helping preserve the natural aroma and sensory identity of the original wines. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005959301/en/ Fürst von Metternich Riesling Alcohol-free on the bottling line, one of the first products in Henkell Freixenet’s portfolio developed in collaboration with Solos Technology. The project combines Henkell Freixenet's longstanding winemaking expertise with Solos' proprietary dealcoholization and patented aroma recovery technology. With 30 years of experience in producing alcohol-free sparkling wines, Henkell Fre
Croma-Pharma Expands Its Portfolio in Canada With saypha ® lips Lidocaine and Exprecell™5.10.2026 14:12:00 EEST | Press release
Croma-Pharma continues to build its portfolio in Canada, adding saypha® lips Lidocaine, a hyaluronic acid filler for lip augmentation,1 and Exprecell™, a medical device for the preparation of autologous PRP | Fluid-PRF.2 Both are distributed by Renellence, Croma's partner in Canada since 2025. The two additions reflect Croma's broader approach: pairing established hyaluronic acid expertise with autologous, regenerative technologies. Together, they give practitioners options across both aesthetic and regenerative treatment categories, from a single trusted source. "With saypha® lips Lidocaine and Exprecell™, we're giving Canadian practitioners a wider set of tools for facial aesthetics and regenerative treatments, each held to the same standard of precision and safety," said Andreas Prinz, Chief Executive Officer of Croma-Pharma GmbH. Renellence has distributed Croma's Saypha® hyaluronic acid filler range in Canada since October 2025, alongside medical education and training for Canadia
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