Ferrer Receives FDA Fast Track Designation for FNP-223 to Treat Progressive Supranuclear Palsy
Wednesday, June 18, 2025
Ferrer, a global pharmaceutical company and certified B Corp, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for FNP-223, a treatment aimed at slowing the progression of progressive supranuclear palsy (PSP). The therapy, originally licensed from Asceneuron, is currently being evaluated in a Phase 2 clinical study involving adults diagnosed with possible or probable PSP-Richardson syndrome—the most frequent form of the disease.
Fast Track designation is granted to therapies that have the potential to address serious conditions with limited treatment options. This status allows companies to engage more closely with the FDA throughout the development process and may help speed up the review and approval of promising medicines.
PSP is a rare, progressive brain disorder that causes symptoms such as difficulty with balance and walking, problems with speech, and cognitive decline. It typically affects individuals over the age of 60 and is believed to result from the abnormal build-up of tau proteins in certain areas of the brain. These protein accumulations lead to the degeneration of nerve cells and impair brain function.
FNP-223 is an investigational oral therapy designed to block the activity of an enzyme known as O-GlcNAcase (OGA). By inhibiting this enzyme, FNP-223 prevents the removal of specific sugar-based modifications (O-GlcNAc) from tau proteins. This action is expected to reduce the build-up of abnormal tau aggregates—also known as neurofibrillary tangles—which are linked to the progression of PSP.
In preclinical studies, FNP-223 showed the potential to prevent tau accumulation in neurons. The ongoing Phase 2 trial is assessing the safety, effectiveness, and drug behaviour in the body of FNP-223 in people with PSP. Ferrer’s aim is to provide a new treatment option for patients with this challenging and life-limiting condition.
Source: businesswire.com
