AZP2006: clinical trials
AZP2006 is an orally available drug candidate developed to act on the main physiopathological hallmarks of Alzheimer's disease and related tauopathies such as Progressive Supranuclear Palsy (PSP). AZP2006 is not positioned as a symptomatic treatment, it aims at slowing down the disease progression.
Phase 1 Clinical Trials
In 2015, we performed the first clinical trials on heathy volunteers (male aged between 18 and 55). These randomized, placebo-controlled studies allowed evaluating the safety, tolerability and pharmacokinetics of several doses of AZP2006 during a short 10 days treatment. AZP2006 was well tolerated.
In 2016, we will continue these studies on healthy volunteers (male and female aged over 65), with a longer 28 day treatment period.
Future Clinical Development Plan
Our goal is to rapidly set up a first Phase 2 study on PSP patients in order to demonstrate the biological effects of AZP2006 on the central nervous system.
The European Medecines Agency 'orphan désignation' of AZP2006 for the treatment of PSP will allow us to accelerate our development program with a single pivotal study in 2018.
Positive Phase 2 results on PSP patients will support the evaluation of AZP2006 in other neurodegenerative pathologies such as Alzheimer's disease.