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 trials.
Our current clinical programs include birtamimab for the potential treatment of AL amyloidosis, prasinezumab for the potential treatment of Parkinson’s disease, coramitug (PRX004) for the potential treatment of ATTR amyloidosis, BMS-986446/PRX005 and PRX012 for the potential treatment of Alzheimer’s disease, and PRX019 a potential treatment of neurodegenerative diseases.
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 clinical trial (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 (NCT04777331) and the Phase 2 PASADENA (NCT03100149) clinical trials are ongoing in an open label extension period evaluating prasinezumab in participants with early Parkinson’s disease. Both clinical trials are being conducted by our partners at Roche.
Coramitug (PRX004) is a humanized monoclonal antibody being developed for the potential treatment of ATTR amyloidosis. The Phase 1 clinical trial (NCT03336580) is complete. Novo Nordisk has acquired Prothena’s coramitug (PRX004) and is conducting the ongoing Phase 2 clinical trial (NCT05442047) in patients with ATTR cardiomyopathy. More information on the acquisition can be found here.
BMS-986446 (PRX005), a potential best-in-class antibody for the treatment of Alzheimer’s disease that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal human biology of Alzheimer’s disease. BMS-986446 is part of a Global Neuroscience Research and Development Collaboration with Bristol Myers Squibb. Bristol Myers Squibb is enrolling approximately 475 patients with early Alzheimer’s disease into a Phase 2 clinical trial; primary completion is expected in 2027 (NCT06268886).
PRX012 is an anti-amyloid monoclonal antibody, designed for once-monthly subcutaneous administration, that targets a key epitope at the N-terminus of amyloid beta (Aβ) being developed for the potential treatment of Alzheimer’s disease. The ASCENT Phase 1 clinical trials for PRX012 are ongoing. ASCENT-1 will evaluate the safety, tolerability, and immunogenicity following a single dose of PRX012 in healthy volunteers and patients with Alzheimer’s disease. ASCENT-2 will evaluate the safety, tolerability, immunogenicity, and the effect on brain amyloid plaque after multiple doses of PRX012 in patients with Alzheimer’s disease. Patients may choose to continue once monthly treatment of PRX012 in an open label extension for 12 months.