The submission is scheduled for mid-2024, following constructive pre-submission meetings with EU regulatory authorities.
The company also plans to engage with the US Food and Drug Administration (FDA) to explore potential pathways for pridopidine’s approval in the country.
Prilenia plans to extend its regulatory submissions globally after the European review process.
Prilenia CEO Dr Michael Hayden said: “Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families. These measures include day-to-day function, cognition, motor and clinical progression in people living with HD.
“The benefits are clearly evident in those with HD who are not taking anti-dopaminergic medications (ADM).
“We appreciate the constructive discussions with European regulators regarding our data for pridopidine. This provides a pathway to potential approval of a therapy for HD, a rare neurodegenerative disease with a predictable decline, and no currently approved treatments that address progression.”
In January 2024, Prilenia revealed successful discussions with global regulatory agencies concerning pridopidine’s development for amyotrophic lateral sclerosis (ALS), with a pivotal Phase III study in the pipeline.
The PROOF-HD study, a Phase III trial, assessed pridopidine’s safety and efficacy in individuals with HD across multiple countries, including the US, Canada, and several European nations. The trial involved 499 participants and administered pridopidine (45mg twice daily) over 65-78 weeks.
Pridopidine, an oral S1R agonist, has demonstrated a safety and tolerability profile comparable to placebo in clinical trials.
Prilenia has secured orphan drug designation for pridopidine in both HD and ALS in the US and EU, and the FDA granted fast track designation for HD treatment.