SEONGNAM-SI, South Korea--(BUSINESS WIRE)--AriBio Co., Ltd. (AriBio) announced authorisation from the European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01), a global, phase 3, early Alzheimer’s disease clinical trial. EMA now aligns with the U.S. Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Clinical Trial Authorisation of POLARIS-AD.
AriBio Licenses Exclusive Marketing Rights for AR1001 for AD in China for $770M
SEONGNAM-SI, South Korea--(BUSINESS WIRE)--AriBio Co., Ltd. (AriBio) receives Notice of Acceptance for POLARIS-AD, a Phase 3 early Alzheimer’s disease clinical trial from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK). The MHRA completed their review on the 21 of February and confirmed a favorable ethical opinion, the Company expects to initiate the clinical trial before the end of Q1’2024 in the UK.
AriBio Co., Ltd. Announces Global Expansion of POLARIS-AD
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)
AriBio Co., Ltd. and Fujirebio Diagnostics, Inc. Announce Strategic Partnership to Advance Biomarker Development for Alzheimer’s Disease and Neurodegeneration
SAN DIEGO--(BUSINESS WIRE)--AriBio USA, a clinical-stage biopharmaceutical company, announced the enrollment of their first participants in their Phase 3 trial to evaluate the efficacy of AR1001 in participants with early Alzheimer’s Disease (AD). AR1001 is a blood-brain barrier penetrating small molecule known to inhibit neuron apoptosis and promote neurogenesis, increase neuroplasticity and increase autophagy activity to remove toxic proteins.
SEONGNAM, South Korea--(BUSINESS WIRE)--Today AriBio Co., Ltd. announced the completion of the end of phase 2 meeting (EOP2) with the United States Food and Drug Administration (FDA), Division of Neurology 1. The EOP2 meeting, which occurred April 28th on Thursday morning Eastern Standard Time (EST), included several individuals from different departments within the FDA, including non-clinical, clinical, biostatistics, and Dr. Billy Dunn, the Director from the Office of Neuroscience. “AriBio is very appreciative of the time and attention the FDA provided in preparation for and during this EOP2 meeting,” said James Rock, CEO of AriBio USA, INC.
Huons has signed an agreement with AriBio, a biotech firm specializing in medicines for neurodegenerative and infectious disease, to develop new brain disease and dementia drugs targeting the global market.