20 October | 2021
Prilenia and Huntington Study Group Announce Completion of Patient Enrollment Ahead of Schedule in Global Phase 3 PROOF-HD Huntington’s Disease Clinical Trial
Pridopidine is the most advanced drug candidate in clinical development for maintenance of functional capacity in Huntington’s Disease
Naarden, NL, 20 October 2021 – Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced the completion of patient enrollment in the Pridopidine Outcome On Function in Huntington’s Disease (PROOF-HD) global Phase 3 clinical trial.
PROOF-HD is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of pridopidine in individuals with early stage Huntington’s Disease (HD). The trial is being conducted in the U.S., Canada and nine countries in Europe. This study is being undertaken in collaboration with the Huntington Study Group (HSG), a world leader in clinical research for HD.
The aim of the study is to evaluate pridopidine’s impact on Total Functional Capacity (TFC) score as the primary endpoint. TFC is a validated, clinically meaningful and regulatory accepted endpoint that measures the patient’s ability to maintain function in different domains. Pridopidine acts as a highly selective and potent Sigma-1 receptor (S1R) agonist and has been shown to maintain functional capacity in early HD patients in a prior trial. Currently, pridopidine is the only Phase 3 clinical stage drug candidate assessing progression as measured by TFC in HD.
“We are proud to reach this significant milestone for pridopidine as we work diligently to provide a much-needed treatment option for the patients and families faced with this challenging disease,” said Dr. Michael R. Hayden, CEO and Founder of Prilenia. “Thanks to the support of HSG, the Clinical Trials Coordination Center (CTCC) and TFS, we have been able to reach this milestone well ahead of schedule and with numbers over our enrollment target of 480 participants, despite the global pandemic. We are also deeply grateful to the clinical site teams and the HD community globally for supporting this trial. Our lead asset, pridopidine, has previously demonstrated a favorable long-term safety and tolerability profile and we are currently on track to obtain PROOF-HD’s top-line results in Q1 2023.”
"Completing the enrollment of the PROOF-HD clinical trial brings us closer to finding more effective treatments for Huntington’s Disease and reducing the burden for families affected by the disease", said Dr. Andrew Feigin, MD, Chair at The Huntington Study Group. "If successful, data from the Phase 3 PROOF-HD trial has the potential to make a large positive impact on the Huntington’s Disease community, and we look forward to continuing this clinical trial in partnership with Prilenia."
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