Henk Schuring, Chief Regulatory and Commercialization Officer at Prilenia Therapeutics, discusses the PROOF-HD Huntington disease clinical trial, which has completed its patient enrollment ahead of schedule.
Huntington disease is an inherited, neurodegenerative disorder that usually begins to be symptomatic at around the age of 40 years. Persons with Huntington disease suffer from a progressive movement disorder, cognitive decline, psychiatric disturbances, and behavioral symptoms. All symptoms progress which eventually leads to immobility, dementia, and premature death.
As Mr. Schuring explains, the PROOF-HD trial is a pivotal trial being conducted in North America and Europe as collaboration between Prilenia and the Huntington Study Group. The first U.S. subjects were enrolled in October 2020. The trial was fully recruited about a month ahead of schedule despite the Covid-19 pandemic, and top-line results are expected in Q1 2023.
The purpose of the PROOF-HD study is to evaluate the efficacy and safety of pridopidine in patients with early stage Huntington disease. The primary endpoint is Total Functional Capacity, which measures the patient’s ability to maintain function in different domains. This includes tasks like managing their own finances or picking up their young children or grandchildren.
To learn more about Huntington disease and other rare neurological disorders, visit checkrare.com/diseases/neurology-nervous-system-diseases/