Ferrer has announced that its investigational therapy FNP-223, developed to treat progressive supranuclear palsy (PSP), has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The designation is expected to accelerate the development and review process for the drug, which is currently in Phase 2 clinical trials.
FNP-223, a novel small molecule in-licensed from Swiss biotech firm Asceneuron, is being evaluated in adult patients diagnosed with possible or probable PSP-Richardson syndrome (PSP-RS) — the most common form of this rare neurodegenerative disorder. The ongoing Phase 2 study is assessing the drug’s safety, efficacy, and pharmacokinetics.
PSP is characterized by symptoms such as impaired balance, speech difficulties, abnormal eye movements, cognitive decline, and stiffness. It primarily affects individuals over 60 and has an estimated prevalence of 5 per 100,000 people. The disease is linked to the abnormal buildup of tau proteins in the brain, leading to progressive neurodegeneration. Preclinical studies suggest that FNP-223 may block this tau accumulation in neurons.
“This is a major step forward in our effort to develop a treatment for PSP,” said Mario Rovirosa, CEO of Ferrer. “The Fast Track designation reflects our deep commitment to bringing hope to patients affected by this devastating disease.”
The FDA’s Fast Track program is designed to expedite the development of drugs that address serious or life-threatening conditions and fulfill an unmet medical need. Benefits include more frequent meetings with the FDA, eligibility for Accelerated Approval and Priority Review, and a rolling submission process for marketing applications.
Marta Parmar, Ferrer’s Chief Quality, Regulatory and Pharmacovigilance Officer, emphasized the urgency: “This designation highlights the critical need to speed up development of therapies like FNP-223 for PSP, where no disease-modifying treatments currently exist.”
Oscar Pérez, Chief Scientific Officer at Ferrer, added, “Our goal is to provide a transformative option for patients as early as possible. We’re excited to continue the clinical development of FNP-223.”
As Ferrer advances FNP-223 through clinical evaluation, the Fast Track status offers an opportunity to potentially deliver the therapy to patients faster—offering new hope in a field where therapeutic options are limited.