
Clinical
Trials
At Prothena, every step we take to heal, cure and prevent disease, we take in collaboration with the patients and their families who generously participate in clinical studies.
Our current clinical programs include birtamimab for the potential treatment of AL amyloidosis, prasinezumab for the potential treatment of Parkinson’s disease, NNC6019/PRX004 for the potential treatment of ATTR amyloidosis, and PRX005 and PRX012 for the potential treatment of Alzheimer’s disease.
Birtamimab is a humanized monoclonal antibody being developed for the potential treatment of patients with Mayo Stage IV AL amyloidosis. The confirmatory Phase 3 registration enabling AFFIRM-AL study (NCT04973137) evaluating the efficacy and safety of birtamimab in patients with Mayo Stage IV AL amyloidosis is ongoing under a Special Protocol Assessment (SPA) agreement with the FDA.
Prasinezumab is a humanized monoclonal antibody being developed for the potential treatment of Parkinson’s disease, and is the focus of a worldwide collaboration between Prothena and Roche. The Phase 2b PADOVA study (NCT04777331) evaluating the efficacy and safety of prasinezumab in patients with early Parkinson’s disease is ongoing. Also, the open label extension portion of the Phase 2 PASADENA study (NCT03100149) evaluating prasinezumab in participants with early Parkinson’s disease is ongoing. Both studies are being conducted by our partners at Roche.
NNC6019/PRX004 is a humanized monoclonal antibody being developed for the potential treatment of ATTR amyloidosis. The Phase 1 study (NCT03336580) is complete. Novo Nordisk has acquired Prothena’s NNC6019/PRX004 and is conducting the ongoing Phase 2 study (NCT05442047) in patients with ATTR cardiomyopathy. More information on the acquisition can be found here.
PRX005 is a humanized monoclonal antibody being developed for the potential treatment of Alzheimer’s disease and is the first target of three in a collaboration with Bristol Myers Squibb. The Phase 1 single ascending dose (SAD) portion of the study in healthy volunteers demonstrated dose-proportional PRX005 concentrations in plasma with robust central nervous system (CNS) penetration of this potentially best-in-class investigational anti-MTBR-tau antibody. Single doses of PRX005 across three dose cohorts were generally safe and well tolerated, meeting the primary objective of the study. The Phase 1 multiple ascending dose (MAD) portion of the study is ongoing in healthy volunteers and patients with Alzheimer’s disease. The PRX005 program is being conducted by our partner Bristol Myers Squibb.
PRX012 is a next-generation monoclonal antibody being developed for the potential treatment of Alzheimer’s disease. The Phase 1 study with PRX012 is ongoing.