Ferrer, a B Corp-certified international pharmaceutical company, has initiated a Phase II clinical trial (PROSPER) to assess the safety and efficacy of FNP-223 in slowing the progression of Progressive Supranuclear Palsy (PSP). The first participant has been dosed, marking a significant step in developing a much-needed therapy for this rare neurodegenerative disease.
The PROSPER trial is designed as a randomized, double-blind, placebo-controlled study. It includes a 52-week treatment period followed by a 4-week follow-up. The trial aims to enroll up to 220 participants across 46 clinical trial sites in the United States, the United Kingdom, and seven countries within the European Union. Recruitment is currently underway in the United States, with expansion to other countries anticipated in the fourth quarter of 2024.
FNP-223: Targeting Tau Protein Accumulation
FNP-223 is a novel therapy designed to prevent the abnormal accumulation of tau proteins in neurons, a hallmark of PSP. Preclinical models have demonstrated that FNP-223 can indeed prevent this accumulation. Ferrer now seeks to confirm these findings in humans, assessing both the safety and efficacy of the molecule in PSP patients.
Óscar Pérez, Chief Scientific Officer of Ferrer, stated, "The inclusion of the first participant into the PROSPER clinical trial marks an important milestone in our commitment to find transformative solutions for people living with PSP." He added that the drug's effect on tau protein could potentially slow the disease's progression.
Progressive Supranuclear Palsy: An Unmet Need
Progressive Supranuclear Palsy is a rare and devastating neurodegenerative disease affecting approximately 5 in 100,000 people annually. It primarily affects individuals over the age of 60 and is slightly more prevalent in men. PSP manifests with symptoms including difficulty speaking, imbalance, gait changes, cognitive impairment, impaired eye control, and swallowing difficulties.
Currently, there is no cure for PSP, and treatment options are limited to alleviating symptoms. The underlying cause is believed to be related to the abnormal accumulation of tau protein in specific brain regions, leading to neurodegeneration. The average survival from the onset of symptoms is approximately seven years.
Patient Advocacy in Trial Design
Ferrer emphasizes the importance of patient input in their research and development efforts. Jorge Cáneo, Chief Medical Officer of Ferrer, noted that CurePSP and PSPA UK, two leading patient associations, participated in the design of the PROSPER trial. This collaboration ensures that the trial addresses the most critical needs and concerns of patients and their caregivers.
Kristophe Diaz, Executive Director and Chief Science Officer of CurePSP, expressed support for the PROSPER study, stating, "The start of phase II for the PROSPER study represents a significant step in the search for treatments for this currently incurable disease, so we are delighted to collaborate with Ferrer and be able to contribute to this important milestone for our community."
