17 November | 2021
Forbion Portfolio Company Prilenia receives Fast Track Designation for Treatment of Huntington’s Disease
Naarden, NL, 17 November 2021 – Forbion, a leading European life sciences venture capital firm, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pridopidine for development as a potential treatment for Huntington’s Disease (HD). Pridopidine is being developed by Prilenia Therapeutics BV (Prilenia), a Forbion portfolio company.
Fast Track designation may accelerate the registration process for Pridopidine by providing the ability to file a rolling new drug application (NDA) and qualify for priority review.
Pridopidine acts as a highly selective and potent Sigma-1 Receptor (S1R) agonist and is currently being assessed in PROOF-HD (PRidopidine Outcome On Function in Huntington Disease), a global phase 3 clinical trial. Prilenia recently announced the completion of enrolment in the PROOF-HD clinical trial ahead of schedule.
Geert Jan Mulder MD, Chairman of Prilenia and Managing Partner at Forbion commented: “This news emphasizes the potential future impact of the Pridopidine programme and the hope for patients with Huntington’s Disease and their families, while also marking another major milestone for the Company. The team at Prilenia again demonstrates outstanding execution of the ongoing development program of this promising therapeutic with the potential to help those living with Huntington’s Disease, a large population of individuals with high unmet need.”
Dr. Michael R. Hayden, CEO and Founder of Prilenia commented: “Receipt of Fast Track designation from the FDA underscores the urgency to address a significant unmet need for patients with Huntington’s Disease. HD is one of the most devastating neurodegenerative disorders, impacting not only patients but their families. At the present time, there is no approved treatment to delay onset or slow the disease's progression. We look forward to working closely with the FDA to making pridopidine a potential option for these patients.”
Pridopidine is orally administered with therapeutic potential in HD, ALS and other neurodegenerative diseases and neurodevelopmental disorders such as Rett and Fragile-X syndromes.