Prilenia Phase 3 Trial with Pridopidine –
Why is it Different?

– Written by the Moving Forward team on September 12th, 2022

For all those who have been following Huntington’s disease research for some time, Pridopidine is an “old acquaintance”. To date, several studies have been conducted with this drug, looking closely to its effect on dopamine. Although they have helped us to confirm the safety and good tolerability of pridopidine, none of these trials has been completely successful.

A previous study called PRIDE-HD, which was a collaboration between the Huntington Study Group and the European Huntington Disease Network sponsored by Teva Branded Pharmaceutical Products, proved that pridopidine is able to maintain functional capacity in patients with early manifest HD, as measured by the Total Functional Capacity scale.

Thus, Prilenia, a clinical stage biotech company, has decided to give pridopidine another try and is currently conducting a global Phase 3 clinical trial with this orally administered drug. The trial is called PROOF-HD (PRidopidine Outcome On Function in Huntington Disease (PROOF-HD) and is running since the end of 2020 in the US, Canada and some European countries.   

The goal is to evaluate the impact of pridopidine on the functional capacity and motor and behavioural symptoms of 499 patients with early manifest HD. Despite all the difficulties caused by the Covid-19 pandemic, patient recruitment was successful and was completed ahead of schedule. The results of this study are expected to be out in the first quarter of 2023.

The Moving Forward team is following this trial with great interest. Specifically, the team had the chance to meet with some of the clinicians running the PROOF-HD study in Spain and discuss their experience with this and other trials. We believe that the feedback provided by this meeting will be crucial to help us improve the research experience of the Spanish HD community.

More details about Prilenia and PROOF-HD can be found here: