Spanish pharmaceutical company Ferrer announced that its experimental drug for progressive supranuclear palsy (PSP) has received a Fast Track designation from the United States Food and Drug Administration (FDA).  

Fast Track Designation Brings Closer Cooperation with FDA 

The FDA uses its Fast Track designation to help the development of a drug and expedite its review to address an unmet medical need. Now that Ferrer’s drug, FNP-223, has received the designation, the company can schedule more frequent meetings with regulators and submit documentation sooner. Additionally, FNP-223 is potentially eligible for accelerated or priority review from the FDA if it meets the requirements.  

“We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP,” said Ferrer CEO Mario Rovirosa. “Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible.” 

What Is FNP-223, and How Could It Treat PSP? 

FNP-223 is an orally delivered drug designed to protect the tau protein, which helps maintain specific structures in nerve cells called neurons. But tau can malfunction, creating protein tangles that are toxic to the brain. PSP, a disorder with primarily movement-based symptoms, is one of a few FTD subtypes caused by tau dysfunction.  

Tau is typically protected from dysfunction by an enzyme called OGT, which forms a protective layer around the protein. However, a different enzyme, OGA, can remove this protective barrier, raising the risk of tangle formation. By blocking the OGA enzyme with FNP-223, Ferrer hopes to protect tau from malfunctioning. 

Prosper Clinical Trial Recruiting Participants 

The Prosper clinical trial evaluating FNP-223 is recruiting participants at over 40 sites in the United States, the United Kingdom, and several European Union member states. To learn more about the trial, including participation criteria and study sites, visit the Prosper clinical trial website. If you have questions about participating in a clinical study, reach out to AFTD’s HelpLine at 1-866-507-7222 or info@theaftd.org. 

Are you interested in participating in other studies for FTD? Sign up at the FTD Disorders Registry to learn of recruiting studies when they match your interests. You may also be eligible for the online Registry Research Study to share insights about diagnosis, family history, lived experience, genetic testing, medical records, and more. Numbers have power. The more participants, the more we can help researchers design studies for which people are ready and willing to participate.