Irish biotechnology firm Prothena has dosed the first patient in its second Phase I multiple ascending dose clinical trial of PRX002, a potential treatment for Parkinson’s disease (PD).
PRX002 is a monoclonal antibody targeting a-synuclein. It has been evaluated in several cellular and animal models of synuclein-related disease.
This first dosing in the second Phase I trial is based upon safety and tolerability observed in the ongoing Phase I single ascending dose trial of PRX002 in healthy volunteers.
About 60 patients with PD will be enrolled for the randomised, double-blind, placebo-controlled, multiple ascending dose Phase I trial at multiple centres across the US.
The multiple ascending dose escalation Phase I trial will assess the safety, tolerability, pharmacokinetics and immunogenicity of PRX002, and will also evaluate multiple clinical and exploratory biomarkers.
In the trial, patients will be enrolled in escalating dose cohorts of PRX002 or a placebo and will be observed for up to six months.
Prothena president and CEO Dale Schenk said: "We are extremely pleased to initiate this study of PRX002 in patients with Parkinson’s disease.
"Building on our robust preclinical studies that demonstrated targeting a-synuclein led to both functional and cognitive improvement in animal models of Parkinson’s disease, together with Roche, we are excited for the opportunity to assess PRX002 in patients with Parkinson’s disease."
In December 2013, the company entered into a collaboration with Roche to develop and commercialise antibodies that target a-synuclein, including PRX002.
So far, the company has received $45m of the potential $600m in total milestones through its collaboration with Roche.
Prothena is focused on the discovery, development and commercialisation of new antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion.