Irish clinical stage biotechnology firm Prothena has started dosing patients in a Phase I clinical trial of PRX002, the company’s therapeutic monoclonal antibody candidate targeting a-synuclein, for the treatment of Parkinson’s disease (PD).
In addition, the company has earned a $15m milestone payment from Roche related to the start of the trial.
The randomised, double-blind, placebo-controlled, single ascending dose trial is designed to evaluate PRX002 in healthy subjects for safety, tolerability, pharmacokinetics and immunogenicity.
Prothena president and chief executive officer Dale Schenk said: "Together with Roche, we look forward to advancing this potential disease-modifying treatment for Parkinson’s disease and other related synucleinopathies through clinical development."
In December 2013, Prothena had entered into a worldwide collaboration with Roche for the development and commercialisation of new antibodies that target a-synuclein, including PRX002.
Together with the current milestone payment, the company has now achieved a total of $45m through its worldwide PRX002 collaboration with Roche.
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PRX002 has already been tested in various cellular and animal models of synuclein-related disease.
The company said that passive immunisation with 9E4, the murine version of PRX002, in several transgenic mouse models of PD reduced the appearance of synuclein pathology, protected synaptic connections and improved performance by the mice in behavioural testing.
PRX002 is expected to slow or reduce the progressive neurodegeneration associated with synuclein misfolding and/or the cell-to-cell transmission of the pathogenic forms of synuclein.
a-synuclein, is found in neurons and is an important component of pathological inclusions that characterise several neurodegenerative disorders, including PD, dementia with Lewy bodies, neurodegeneration with brain iron accumulation type 1, and multiple system atrophy, which collectively are termed synucleinopathies.