Ferrer Progresses PSP Research with First Phase II Trial Participant

BARCELONA, Spain I September 17, 2024 I Ferrer, a B Corp-certified global pharmaceutical company, has initiated the dosing of the first participant in its Phase II clinical trial named PROSPER. This study aims to assess the safety and effectiveness of an innovative molecule, FNP-223, which is being developed to slow the progression of Progressive Supranuclear Palsy (PSP).

The PROSPER trial is a randomized, double-blind, placebo-controlled Phase II clinical study. Participants will undergo a 52-week treatment period followed by a 4-week follow-up period. The study plans to involve up to 220 participants across 46 clinical trial sites situated in the United States, the United Kingdom, and seven European Union countries. Recruitment is currently underway in the United States, with additional countries expected to commence recruitment in the fourth quarter of 2024.

Óscar Pérez, Chief Scientific Officer of Ferrer, expressed enthusiasm about this phase of their research, stating, "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."

Progressive Supranuclear Palsy is a rare, neurodegenerative disorder with no existing cure, though treatments can help alleviate symptoms. Patients with PSP experience difficulties such as impaired speech, imbalance, altered gait, cognitive issues, challenges with eye control, trouble swallowing, and other related symptoms. This rare disease has an incidence rate of approximately 5 cases per 100,000 people annually, predominantly affecting individuals over 60 years of age and being slightly more prevalent among men. The exact cause of PSP remains unknown, but it is believed to be linked to the abnormal accumulation of tau protein in specific brain regions, leading to neurodegeneration and the hallmark symptoms of the disease. The average survival period from the onset of PSP is seven years.

Preclinical models have demonstrated that the administration of FNP-223 can prevent the abnormal accumulation of tau proteins in neurons. Ferrer now aims to prove that this molecule is both safe and effective for patients with PSP. Pérez noted, "Its effect on the tau protein could represent a therapeutic treatment capable of slowing down the development of this rare neurodegenerative disease."

Jorge Cúneo, Chief Medical Officer of Ferrer, emphasized the company's focus on improving the lives of people with rare diseases and advocating for social justice. He highlighted the importance of understanding the needs of patients and caregivers, mentioning that major patient associations like CurePSP and PSPA UK have participated in designing the PROSPER trial.

Kristophe Diaz, Executive Director and Chief Science Officer of CurePSP, expressed support for the PROSPER trial, stating, "Our organization supports innovative research and clinical trials that offer hopes to people living with Progressive Supranuclear Palsy. The start of Phase II for the PROSPER study represents a significant step in the search for treatments for this currently incurable disease. We are delighted to collaborate with Ferrer and contribute to this important milestone for our community."

In summary, Ferrer's PROSPER trial represents a significant advancement in the quest to develop a treatment for Progressive Supranuclear Palsy. With the initiation of the study, Ferrer aims to bring hope and potential solutions to those affected by this devastating neurodegenerative disease.