- A 40-subject Phase 1 single ascending dose study evaluating the safety of Prothena's (NASDAQ:PRTA) investigational monoclonal antibody for the treatment of Parkinson's disease (PD), PRX002, met its primary endpoint of safety and tolerability. All PRX002-related adverse events were mild and no dose-limiting toxicities were seen.
- Results from the study also showed that treatment with PRX002 reduced mean free serum alpha-synuclein levels, a protein involved in the onset and progression of PD, up to 96%, with a strong, rapid, dose-dependent response after a single dose.
- A multiple ascending dose trial assessing the safety and tolerability of PRX002 is ongoing. The product candidate is being jointly developed with Roche (OTCQX:RHHBY).
- Alpha-synuclein is a protein found in neurons. Its normal function is not well understood, but in synucleinopathies (e.g. PD, Lewy body dementia, multiple system atrophy) the protein can misfold and aggregate to form soluble aggregates and insoluble fibrils that contribute to the pathology of the disease. There is also increasing evidence that disease-causing synuclein can be propagated and transmitted from neuron to neuron, resulting is an infection-like spread of neuronal death.
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PRX002 is designed to slow or reduce the progressive degradation of neurons associated with synuclein misfolding and/or the cell-to-cell transmission of pathogenic synuclein.
- Previously: Prothena +5.3% AH, inks collaboration deal with Roche for Parkinson's antibodies (Dec. 11, 2013)