BARCELONA, Spain / NAARDEN, The Netherlands and WALTHAM, Mass., June 16, 2026 – Ferrer and Prilenia Therapeutics B.V. today announced the inclusion of the first participant in Europe in PREVAiLS (EUCT: 2025-524002-16-00/NCT07322003), the global Phase 3 clinical trial evaluating the efficacy and safety of pridopidine in people with amyotrophic lateral sclerosis (ALS) in early stages of the disease, with Dr. Henk-Jan Westeneng as principal investigator. The participant has been included in the University Medical Center of Utrecht (Netherlands), one of the reference centers in ALS research worldwide, under the direction of Prof. Leonard van den Berg. It is expected that other European centres will start including participants in the near future.
This milestone is a significant step in the advancement of research for people with ALS, a devastating neurodegenerative disease in which significant unmet medical needs persist. The PREVAiLS clinical trial is already in the recruitment phase in all regions.
ALS is a progressive neurodegenerative disease that has a profound impact on patients, as well as their families and caregivers. Despite advances in research, treatment options remain limited for many people with this disease, highlighting the need to continue to drive research, development and scientific innovation.
Dr. Henk-Jan Westeneng, principal investigator of the PREVAiLS clinical trial and member of the Department of Neurology at University Medical Center Utrecht, said: "ALS remains a disease with significant unmet medical needs. The PREVAiLS clinical trial represents a significant effort to generate solid clinical evidence and continue to advance the understanding of new possible approaches."
Prof. Dr. Leonard van den Berg, Chair of The European Research Initiative to find a Cure for ALS (TRICALS), Professor of Neurology at University Medical Center Utrecht and member of the PREVAiLS Steering Committee, said: "Despite advances in ALS research, there remains a significant need for therapeutic options for people with this serious and progressive disease. The inclusion of the first participant in Europe is an important milestone for the PREVAiLS clinical trial and reflects the commitment of the ALS research community to advancing research."
Oscar Pérez, Chief Scientific Officer at Ferrer, said: "We believe that no patient should be left behind simply because a disease is rare, complex or difficult to treat. That's why we focus our efforts where the need is greatest and where scientific innovation has the potential to change lives."
[This press release is for informational purposes only. Pridopidine is an investigational medicine and is not approved for commercial use by any regulatory authority. Their safety and efficacy have not been established. The information contained herein does not constitute medical advice. Patients should consult their healthcare professional for guidance on diagnosis or treatment options. Local regulations may vary; This release is not intended to promote or advertise any product.]
About PREVAiLS
PREVAiLS is a randomized (3:2 pridopidine:placebo), placebo-controlled, 48-week study, followed by a 48-week open-label extension phase. The study seeks to include participants with a diagnosis of definitive or probable ALS (El Escorial criteria) and with less than 18 months from the onset of symptoms. The primary endpoint is change from baseline in the mortality-adjusted ALSFRS-R scale 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 and plasma biomarkers.
For more information about this clinical trial, interested people can consult their responsible doctor.
More details about PREVAiLS are available at ClinicalTrials.gov (NCT07322003) / EU Clinical Trial Number: 2025-524002-16-00.
About pridopidine
Pridopidine (45 mg twice daily) is an investigational selective oral sigma-1 receptor (S1R) agonist. S1R is involved in the function and survival of neuronal cells, which is key in neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and Huntington's disease (HD).
Safety and tolerability have been evaluated in clinical studies with more than 1,600 participants (mainly in HD studies), some of whom have received active treatment for a period of up to seven years.
Pridopidine has orphan drug designation for HD and ALS in the United States and the European Union, as well as 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 diseases is currently under clinical investigation.
About ALS
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or commonly referred to as motor neuron disease (MND), is a progressive neurodegenerative disease, meaning a chronic condition that worsens over time as damage occurs in different parts of the nervous system. It affects a specific type of neurons, the motor neurons of the brain and spinal cord, and leads to a gradual loss of muscle function that eventually leads to paralysis and death.
ALS affects approximately 500,000 people worldwide and is more common in men than women. The average survival is between 2 and 5 years. The exact cause of ALS is not fully understood, but it is thought to be due to a combination of genetic and environmental factors.
ALS usually appears in people between the ages of 40 and 70 and presents with a variety of symptoms, including muscle weakness and atrophy, mobility problems 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 affect the quality of life of patients and their families by making it difficult to perform daily activities independently. Current treatment options are limited.
S1R dysfunction has been associated with multiple forms of ALS, and maintaining its functionality may play a key role in protecting neuronal function.
