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8 July  |  2021

Prilenia’s Phase 3 Huntington’s Disease Clinical Trial 
Achieves 50% Enrollment 

  • Prilenia’s global phase 3 trial in Huntington’s Disease (PROOF-HD) is ahead of schedule after enrolling 50% (240) of target 480 participants

  • 120 of the participants were enrolled in the past 6 weeks

  • PROOF-HD is the most advanced clinical trial in HD assessing impact on clinical progression


[Naarden, NL, 8 July 2021]  Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, has passed the milestone of  50% enrollment in its pivotal phase 3 Huntington’s Disease (HD - PROOF-HD) trial.


The trial is investigating Prilenia’s lead candidate, pridopidine, for treatment of Huntington’s Disease. The study reached 25% in May 2021 and enrolled a further 25% in only six weeks, with now over 240 registered early-stage HD patients. There have been no drop-outs, and no safety concerns to date.

The PROOF-HD clinical trial is enrolling patients across 60 sites in Europe and North America, in collaboration with the Huntington’s Study Group (HSG). It was organized and initiated in record time, despite the COVID-19 pandemic and is currently the most advanced clinical trial in this indication.  

Dr. Michael R. Hayden, CEO and Founder of Prilenia, commented: “We are delighted that despite the challenging circumstances of the past year, our pivotal Phase 3 study in HD continues as planned, reaching such a significant milestone in a short time. At our current pace, we will be able to complete enrollment ahead of schedule.”

Dr. Andrew Feign, MD, North American Principal Investigator for the PROOF-HD Phase 3 trial, added: “Rapidly achieving 50% enrollment shows great momentum as we push forward with recruitment for this Phase 3 clinical trial. This is exciting not only for Prilenia, but for the full HD research field.”

For further information, please contact:

Prilenia Therapeutics

Limor Ben Har, COO

Instinctif Partners
Melanie Toyne-Sewell / Agnes Stephens
T: +44 (0) 207 457 2020

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