Ferrer and Prilenia Therapeutics B.V. announced today that the PRECISE-HD study has received authorization to begin in participating EU Member States. The confirmatory Phase 3 trial will evaluate investigational pridopidine in Huntington’s disease (HD). Regulators have listed it under EU CT number 2026-526093-16-00 and NCT07609108.
Recruitment in the EU is expected to start this month. Meanwhile, sites in the US and UK already recruit participants. Canada will follow soon after. As a result, the PRECISE-HD study will now reach patients across several regions.
Dr. Ralf Reilmann, Principal Investigator and member of the PRECISE-HD Steering Committee, shared his view on the milestone.
“The initiation of PRECISE-HD in Europe marks a milestone for the Huntington’s disease research community. This confirmatory Phase 3 study has been designed to build on learnings from previous research and to rigorously evaluate the efficacy and safety of pridopidine in people living with HD. As investigators, we look forward to working with participating centers and the HD community to generate robust evidence that can help us better understand the potential role of the study treatment in HD,” said Dr. Ralf Reilmann, Principal Investigator and member of the PRECISE-HD Steering Committee.
Design and Goals of the PRECISE-HD Study
The global trial will enroll approximately 400 participants. Researchers designed it as a randomized, double-blind, placebo-controlled study. Participants will take pridopidine as an oral capsule twice a day.
The study aims to evaluate the efficacy and safety of the investigational treatment. Moreover, it will generate data for regulatory evaluation. Specifically, the team will assess the clinical effect on disease progression, functional capacity, motor function, cognition, speech, and quality of life.
Leaders Welcome the EU Authorization
Similarly, the patient community welcomed the news. Astri Arnesen, President of the European Huntington Association, commented on the move.
“For people living with Huntington’s disease and their families, every step toward a better understanding of the disease and potential treatment options matters. We welcome the involvement of European centers in PRECISE-HD and the continued focus on outcomes that reflect the realities and priorities of people living with HD and their families,” said Astri Arnesen, President of the European Huntington Association.
Finally, Ferrer’s leadership explained the company’s approach. Oscar Pérez, Chief Scientific Officer at Ferrer, spoke about the partnership with Prilenia.
“At Ferrer, putting our purpose into practice also means taking on complex scientific challenges, while recognizing the uncertainty inherent in research. The authorization to initiate PRECISE-HD in participating EU Member States is a further step in our work with Prilenia. We approach that work with a clear sense of responsibility: to conduct research with integrity and let the evidence lead the way,” said Oscar Pérez, Chief Scientific Officer at Ferrer.
Overall, the EU authorization moves the PRECISE-HD study into its next phase. Therefore, the HD community will follow the trial’s progress closely as recruitment expands.
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News Source: Businesswire.com
