First participant in Europe enrolled in PREVAiLS Phase 3 study of pridopidine in ALS
BARCELONA, Spain / NAARDEN, The Netherlands and WALTHAM, Mass.,16 June 2026 – Ferrer and Prilenia Therapeutics B.V.[i] today announced the enrolment of the first participant in Europe in PREVAiLS (EUCT: 2025-524002-16-00 /NCT07322003), the global Phase 3 study evaluating the efficacy and safety of pridopidine in people living with ALS early in their disease course, with Dr Henk-Jan Westeneng serving as Principal Investigator. The participant was enrolled at University Medical Center in Utrecht (The Netherlands), one of the world’s leading ALS research centres, under the leadership of Professor Leonard van den Berg. Additional European sites are expected to start enrolling participants in the near future.
The milestone marks an important step in advancing research for people living with ALS, a devastating neurogenerative disease where significant unmet needs remain. PREVAiLS is now enrolling in all regions.
ALS is a progressive neurodegenerative disease that profoundly impacts patients, families and caregivers. Despite ongoing advances in research, treatment options remain limited for many people living with the disease, underscoring the need for continued scientific research, development and innovation.
Dr Henk-Jan Westeneng, Principal Investigator of the PREVAiLS clinical trial and member of the Neurology Department at University Medical Center in Utrecht, said: “ALS remains a disease with significant unmet medical need. The PREVAiLS study represents an important effort to generate robust clinical evidence and further advance our understanding of potential new approaches in this field.”
Prof. Dr Leonard van den Berg, Chair of The European Research Initiative to find a Cure for ALS (TRICALS), Professor of Neurology at the University Medical Centre Utrecht, and member of the PREVAiLS Steering Committee said: "Despite progress in ALS research, there remains a significant need for treatment options for people living with this serious and progressive disease. The enrolment of the first participant in Europe is an important milestone for the PREVAiLS study and reflects the commitment of the ALS research community to advancing research.”
Oscar Pérez, Chief Scientific Officer at Ferrer, said: “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.
[This press release is intended for informational purposes only. Pridopidine is an investigational drug and is not approved for commercial use by any regulatory authority. Its safety and efficacy have not been established. Information contained herein does not constitute medical advice. Patients should consult their healthcare provider for guidance regarding diagnosis or treatment options. Local regulations may vary; this release is not intended to promote or advertise any product.]
About PREVAiLS (Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS)
PREVAiLS is a 48-week randomised (3:2 pridopidine: placebo), placebo-controlled study, with a 48-week open label extension phase to follow. The study seeks to enroll participants with definite or probable ALS (El Escorial Criteria) who are within 18 months from first onset of disease symptoms. The primary endpoint of PREVAiLS is the change from baseline in ALSFRS-R adjusted for mortality at 48 weeks. Secondary and exploratory endpoints include survival and measures of speech, respiratory function, bulbar function and quality of life, as well as patient-reported outcomes of communication and plasma biomarkers[ii].
For further information about this study, individuals may consult their treating physician.
More details on PREVAiLS can be found on ClinicalTrials.Gov (NCT07322003) / EU CT Number: 2025-524002-16-00.
About pridopidine
Pridopidine (45 mg twice daily) is an investigational selective, oral sigma-1 receptor (S1R) agonist. The S1R supports neuronal cell function and survival which is essential in neurodegenerative diseases such as ALS and Huntington’s disease (HD).
Safety and tolerability have been assessed across clinical studies involving more than 1,600 participants (mostly from HD studies), some of whom have received active treatment for up to seven years.
Pridopidine has Orphan Drug designation in HD and ALS in the US and EU, and FDA Fast Track designation for the treatment of HD.
Pridopidine is an investigational drug not approved by any regulatory authority. Its role in ALS and other neurological conditions is currently under clinical investigation.
About ALS
Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease or often referred to as motor neuron disease (MND), is a progressive neurodegenerative disease, which means it is a chronic condition that gets worse over time as damage builds up in parts of the nervous system. It affects a specific type of neurons – the motor neurons in the brain and spinal cord – and leads to a gradual loss of muscle function that eventually results in paralysis and death. ALS affects approximately 500,000 people worldwide, and is more frequent in men than in women. The average survival is 2 to 5 years. The exact cause of ALS is not fully understood, but it is believed to be a combination of genetic and environmental factors.
ALS typically appears in individuals aged 40 to 70 and presents a range of symptoms, including muscle weakness and atrophy, mobility issues such as lack of coordination and balance, muscle spasms, difficulty speaking clearly (dysarthria), trouble swallowing (dysphagia), fatigue, and emotional and cognitive changes. Symptoms worsen over time and significantly impact the quality of life of patients and their families by affecting their ability to perform daily activities independently. Current treatment options are limited.
Dysfunction of the S1R has been associated with multiple forms of ALS, and maintaining S1R functionality may play a key role in protecting neuronal function.