PRESS RELEASES

5 January |  2022

Prilenia Announces Completion of Patient Enrollment Ahead of Schedule in the Pridopidine Arm of the HEALEY ALS Platform Trial

Pridopidine is an oral, highly selective and potent Sigma-1 receptor agonist that has demonstrated a favorable safety and tolerability profile 

The HEALEY ALS Platform Trial is the first of its kind in ALS, designed to accelerate development of promising new treatments

Naarden, NL, 5 Jan 2022  Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced the completion of participant enrollment in the pridopidine arm of the HEALEY ALS Platform Trial . The trial is led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and is designed to evaluate the safety and efficacy of multiple drug candidates in people with Amyotrophic Lateral Sclerosis (ALS)

The first participant in the pridopidine regimen - Regimen D (NCT04615923) was enrolled in January 2021, and since then, 163 participants have been enrolled ahead of schedule across 52 sites from the Northeast ALS Consortium (NEALS).

 

“We selected pridopidine to participate in the HEALEY Platform Trial out of approximately 30 investigational treatments due to its demonstrated potential to become a new therapy option for patients with ALS,” said Merit Cudkowicz, MD, MSc, Principal Investigator of the HEALEY ALS Platform Trial and the Director of the Sean M. Healey & AMG Center for ALS at Mass General. “Completing enrollment for the fourth regimen in the Platform Trial brings us closer to discovering new treatments for people living with ALS. The platform trial allows faster recruitment of patients because of shared placebo data across treatment arms.”

 

“We are honored to participate in the trial led by the Healey Center and look forward to our continued collaboration as we work towards our goal and hope to have a positive impact on the ALS community,” said Dr. Michael Hayden, CEO and Founder of Prilenia.

 

Pridopidine has received Orphan Drug Designation for ALS in the U.S. and Europe. In addition to the HEALEY ALS Platform Trial, pridopidine is currently being assessed in PROOF-HD, a global phase 3 clinical trial for Huntington’s Disease (HD). The trial completed patient enrollment ahead of schedule and with numbers over the enrollment target in late 2021. Prilenia recently received Fast Track designation for pridopidine for the treatment of HD

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The HEALEY ALS Platform Trial achieves enrollment goal for its fourth regimen (pridopidine)