Ferrer Advances Research into Progressive Supranuclear Palsy (PSP) with the Inclusion of the First Participant in a Phase II Clinical Trial
September 17 2024 - 5:37AM
Business Wire
Ferrer, a B Corp-certified international pharmaceutical company,
has announced the dosing of the first participant in the Phase II
clinical trial, PROSPER. The study seeks to evaluate the safety and
efficacy of the molecule FNP-223,1 a novel therapy intended to slow
the progression of Progressive Supranuclear Palsy (PSP).1,2
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The PROSPER study is a randomised, double-blind,
placebo-controlled Phase II clinical trial, consisting of a 52-week
treatment period and a 4-week follow-up period.1 It is expected to
include the participation of up to 220 participants and 46 clinical
trial sites across the United States, the United Kingdom and 7
countries in the European Union. PROSPER is currently recruiting in
the United States, with additional countries expected to begin
recruitment in the fourth quarter of 2024.
“We are excited about the idea of being able to advance in this
crucial phase of our research with FNP-223,” said Óscar
Pérez, Chief Scientific Officer of Ferrer. “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
disease that currently has no cure, although there are therapeutic
options that can help alleviate its symptoms. The disease manifests
in patients with difficulty speaking, imbalance, changes in gait,
cognitive problems, difficulties with eye control, swallowing
impairment, and other symptoms.3-5 PSP is a rare but devastating
disease, with a yearly incidence of approximately 5 cases per
100,000 people. It mainly affects people over the age of 60 and is
slightly more common among men4. Although its exact cause is
unknown, the cause is thought to be related to the abnormal
accumulation of tau protein in certain brain areas, which results
in neurodegeneration and the disease’s characteristic symptom
presentation.4,5 The average survival from onset is seven
years.6
After having demonstrated in preclinical models that the
administration of FNP-223 can prevent the abnormal accumulation of
tau proteins in neurons,2 Ferrer now hopes to demonstrate that this
molecule is also safe and efficient 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 focus on improving the experience of people living
with rare diseases and offering them equal opportunities, in line
with our purpose of using business to fight for social justice,”
said Jorge Cúneo, Chief Medical Officer of Ferrer. “For us,
it is essential we hear first-hand the needs of patients and their
caregivers. In this sense, CurePSP and PSPA UK, the main patient
associations worldwide, have participated in the design of the
PROSPER trial.”
According to Kristophe Diaz, Executive Director and Chief
Science Officer of CurePSP, “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, so we are
delighted to collaborate with Ferrer and be able to contribute to
this important milestone for our community".
References
- 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]. Disponible en:
https://www.clinicaltrials.gov/study/NCT06355531. Consultado el
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. Disponible
en: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 H�glinger, G.
(2022), Long-Duration Progressive Supranuclear Palsy: Clinical
Course and Pathological Underpinnings. Ann Neurol, 92: 637-649.
https://doi.org/10.1002/ana.26455
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