Mirodenafil

AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)

Retrieved on: 
måndag, april 29, 2024
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Clinical trial, Safety, Food, Plasma, Mirodenafil, Patient, POLARIS, EMA, GDS, CSF, MHRA, Biomarker, European Medicines Agency, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • The final decision from EMA was completed on April 24th with clinical trial approvals in the following member states: Czech Republic, Denmark, France, Germany, Italy, Spain and The Netherlands.
  • Currently, 1,150 participants are expected to be randomized into the Phase 3 clinical trial across 200 sites globally.

MHRA Issues Notice of Acceptance for POLARIS-AD, a Phase 3 Early Alzheimer’s Disease Trial Sponsored by AriBio Co., Ltd.

Retrieved on: 
söndag, februari 25, 2024
Nursing, Biotechnology, Practice Management, Health, General Health, Pharmaceutical, Neurology, Other Science, Medical Devices, Science, Clinical Trials, EMA, FDA, Food, Mirodenafil, Amyloid, Safety, Biomarker, European Medicines Agency, GDS, POLARIS, Patient, MHRA, CSF, Clinical trial, Plasma, Medication, Pharmaceutical industry

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).

Key Points: 
  • 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.
  • POLARIS-AD is a double-blind, randomized, placebo-controlled, multi-center registration trial to evaluate the efficacy and safety of AR1001 (Mirodenafil) over 52 weeks of treatment in patients with early Alzheimer’s disease.
  • “Acceptance of the POLARIS-AD clinical study in the UK is another achievement in the development of AR1001.