Articles from AriBio Co., Ltd.

Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced the completion of a prospective sample acquisition as part of the strategic partnership to advance the development of biomarkers for Alzheimer’s disease and other neurodegenerative conditions. This milestone marks the fulfillment of AriBio’s commitment to provide plasma and matched cerebral spinal fluid samples from the ongoing Phase 3 trial in early Alzheimer’s disease, POLARIS-AD.

Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced today the attainment of the first milestone in a strategic partnership to advance the development of biomarkers for Alzheimer’s disease (AD) and other neurodegenerative conditions. This milestone marks a key achievement which provides Fujirebio access to clinical samples and data collected as part of the ongoing Phase 3 Alzheimer’s disease study, POLARIS-AD.

AriBio Co., Ltd. (AriBio) announces the expansion of testing for Alzheimer’s disease by entering into a strategic collaboration with Kentucky Clinical Trial Laboratory (KCTL) for the testing of cerebral spinal fluid (CSF) to accurately and efficiently aid in the diagnosis of Alzheimer’s disease using the Lumipulse® system from FujireBio. Samples from AriBio’s POLARIS-AD (AR1001-ADP3-US01) study, a global, Phase 3 early Alzheimer’s disease trial in North America, European Union, United Kingdom, and Korea can be tested for Aβ42/40 ratio with the U.S. Food and Drug Administration (FDA) approved assay on the Lumipulse® system. AR1001-ADP3-US01 is a double-blind, randomized, placebo-controlled, multicenter registration trial to evaluate the efficacy and safety of AR1001 over 52 weeks of treatment in patients with early Alzheimer's disease. The trial is using the FDA and European Medicines Agency (EMA) accepted primary endpoint Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB) and secondary endpoints including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (I-IADL), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), in addition to testing for changes in CSF and plasma biomarkers.

AriBio Co., Ltd. (AriBio), a biotech company dedicated to pioneering treatments for neurodegenerative diseases, announces approval of the Investigational New Drug (IND) application by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the initiation of the Phase 3 Polaris-AD trial in China of AR1001 in early Alzheimer’s Disease (AD) on May 11th, 2024.

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 Co., Ltd. (AriBio), announces signing of exclusive marketing rights for AR1001, an investigational drug for early Alzheimer’s disease, in China for up to $770 million USD.

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. (AriBio) announces the global expansion of the POLARIS-AD study, a phase 3 early Alzheimer’s disease trial into the European Union, United Kingdom, Korea and China. The phase 3 study is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (mirodenafil dihydrochloride) over 52 weeks of treatment in patients with early Alzheimer’s disease. The trial is using the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted primary endpoint Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) as well as secondary endpoints including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), in addition to changes in Cerebrospinal fluid (CSF) and plasma biomarkers levels.

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.

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.

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.

A recently published research article in Nature Aging by a Cleveland Clinic Genomic Medicine Institute (GMI) research team, led by Feixiong Cheng, Ph.D., entitled "Endophenotype-based in silico network medicine discovery combined with insurance record data mining identifies sildenafil as a candidate drug for Alzheimer’s disease” showed the potential of PDE5 Inhibitors in Alzheimer’s Disease (AD). The research finding confirms more than 10 years of pioneering research conducted by AriBio Co., Ltd., a Korean biotech company that began its development of an AD drug with its patent of "Composition for Inhibiting Neurocellular Apoptosis Composition for a PDE5 Inhibitor."

AriBio, a clinical-stage biopharmaceutical company based in South Korea, announced today, the topline results from its phase 2 study of AR1001 in mild to moderate Alzheimer’s disease (AD) patients. AR1001 is a blood-brain barrier penetrating small molecule with polypharmacological mechanisms of action to slow the progression of Alzheimer’s disease.