First European participant enrolled in the PREVAiLS study

The PREVAiLS study, investigating the effect of pridopidine in people with ALS, has enrolled its first participant in Europe. The study, sponsored by Ferrer Internacional SA and Prilenia Therapeutics B.V., aims to enroll 500 participants, at 56 leading ALS centres across 13 countries worldwide, with sites now enrolling participants in the US, Canada, Israel and Europe. TRICALS is proud of its close collaboration with Ferrer and Prilenia, resulting in this important milestone for European ALS patients.

The first patient was enrolled at the University Medical Centre of Utrecht, under the Supervision of Leonard van den Berg, European lead of the PREVAiLS Steering Committee and chair of TRICALS:

The enrollment of the first European patient is an important milestone in our search for new therapeutic options that can help slow down disease progression for those being diagnosed with this devastating disease. The PREVAiLS study represents a shared commitment of TRICALS, Ferrer and Prilenia in advancing rigorous clinical research.

Oscar Pérez, Chief Scientific Officer at Ferrer:

People living with ALS face significant challenges, yet treatment options remain limited. We believe no patient should be left behind simply because a disease is rare, complex or difficult to treat. That is why we focus our efforts where the need is greatest and where scientific innovation has the potential to change lives. The enrolment of the first participant in Europe marks an important step forward for the PREVAiLS study and for the ALS community.

TRICALS support

TRICALS has been involved with the PREVAiLS study from the start. TRICALS has provided extensive support both in the planning and start-up phases of the study and will continue to support the PREVAiLS study through its next stages.

Ruben van Eijk, PhD, Associate professor at the University Medical Centre Utrecht, member of the PREVAiLS Steering Committee, and lead statistician at TRICALS

We are pleased to contribute to this important milestone through our ongoing support and dedication to generating robust and meaningful clinical evidence.

Michael Hayden, Chief Executive Officer at Prilenia:

We are deeply grateful to TRICALS for their tireless work in building the clinical infrastructure that makes clinical trials such as the PREVAiLS Phase 3 study possible – from site selection support and training to operational excellence. Together, we are bringing meaningful hope to patients and families living with ALS

The PREVAiLS study takes place across multiple European ALS centres. On the TRICALS webpage, all participating TRICALS centres can be found that are currently active. Recruitment at additional sites in Europe is expected to commence in the coming weeks and months.

Pridopidine is an investigational drug and is not approved for commercial use by any regulatory authority. Its safety and efficacy have not been established.