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Ferrer advances in PSP: first participant in phase II clinical trial

A person in a laboratory using an automatic pipette to handle samples, wearing a white coat and protective gloves.

Barcelona, 12 September 2024. Ferrer, a certified international B Corp pharmaceutical company, has announced the inclusion of the first participant in the Phase II PROSPER clinical trial. The study seeks to evaluate the safety and efficacy of FNP-2231, a new molecule whose mechanism of action could slow down the progression of progressive supranuclear palsy (PSP)1,2.

 

The PROSPER study is a randomized, double-blind, placebo-controlled phase II clinical trial consisting of a 52-week treatment period and a 4-week follow-up1. The participation of up to 220 participants and 46 clinical centers spread between the United States, the United Kingdom and 7 countries of the European Union is expected, although at the moment it is only active in the United States. In the rest of the countries it will begin throughout the last quarter of 2024. 

 

"We are excited to be able to advance this crucial phase of our research with FNP-223," said Óscar Pérez, Chief Scientific Officer at Ferrer. "The inclusion of the first participant in the PROSPER clinical trial marks an important milestone in our commitment to seek transformative solutions for people living with PSP."

 

Progressive supranuclear palsy is a rare neurodegenerative disease that currently has no cure, although there are therapeutic options that can help relieve its symptoms. These include difficulty speaking and maintaining balance, changes in the way you walk, cognitive problems, eye control and even swallowing, among others3-5. The prevalence of PSP is approximately 5-6 cases per 100,000 people. This rare and highly debilitating disease predominantly affects those over 60 years of age and is slightly more common among males4. Although its exact cause is unknown, it is related to the abnormal accumulation of tau protein in certain areas of the brain, which results in neurodegeneration and the presentation of the characteristic symptoms of PSP 4,5. The median survival rate since its onset is approximately 7 years6.

 

Having proven in preclinical models that the administration of FNP-223 can prevent the abnormal accumulation of tau proteins in neurons2, Ferrer now hopes to demonstrate that this molecule is safe and effective also in patients with PSP. According to Pérez, "its effect on the tau protein could represent a therapeutic treatment capable of slowing down the development of this rare neurodegenerative disease".

 

"At Ferrer we are focused on improving the experience of people living with rare diseases and providing them with equal opportunities, in line with our purpose of using business to fight for social justice," said Jorge Cúneo, Chief Medical Officer at Ferrer. "For us, it is essential to hear first-hand the needs of patients and their caregivers. In this regard, we have had the participation of CurePSP and PSPA UK, the world's leading patient associations, for the design of the PROSPER trial." 

 

In the words of Kristophe Diaz, Executive Director and Scientific Director of CurePSP, "Our organization supports innovative research and clinical trials that offer hope to people living with progressive supranuclear palsy. The initiation of phase II of the PROSPER study represents a significant step in the search for treatments for this disease that currently has no cure, so we are delighted to collaborate with Ferrer and be able to contribute to such an important milestone for our community."

 

References:

  1. ClinicalTrials.gov A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER). ClinicalTrials.gov [Internet]. Available at: https://www.clinicaltrials.gov/study/NCT06355531.
Accessed on 03/06/2024. Retrieved 03/06/2024.
  • Permanne B, Sand A, Ousson S, Nény M, Hantson J, Schubert R, et al. D. O-GlcNAcase Inhibitor ASN90 is a Multimodal Drug Candidate for Tau and α-Synuclein Proteinopathies. ACS Chem Neurosci. 2022 Apr 20; 13(8):1296-1314. DOI: 10.1021/acschemneuro.2C00057. 
  • Coughlin DG, Litvan I. Progressive supranuclear palsy: Advances in diagnosis and management. Parkinsonism Relat Disord. 2020 Apr;73:105-116. doi: 10.1016/j.parkreldis.2020.04.014. Epub 2020 May 25.
  • Agarwal S, Gilbert R. Progressive Supranuclear Palsy. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK526098/ 
  • Rowe JB, Holland N, Rittman T. Progressive supranuclear palsy: diagnosis and management. Pract Neurol. 2021; 21(5):376-383. DOI: 10.1136/practneurol-2020-002794
  • Lukic, M.J., Respondek, G., Kurz, C., Compta, Y., Gelpi, E., Ferguson, L.W., Rajput, A., Troakes, C., , van Swieten, J.C., Giese, A., Roeber, S., Herms, J., Arzberger, T. and Höglinger, G. (2022), Long-Duration Progressive Supranuclear Palsy: Clinical Course and Pathological Underpinnings. Ann Neurol, 92:637-649. https://doi.org/10.1002/ana.26455