FNP-223 for Progressive Supranuclear Palsy

Not currently recruiting at 45 trial locations

Overseen By Lawrence Honig

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ferrer Internacional S.A.

Disqualifiers: Parkinson's, Alzheimer's, PSP mutation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FNP-223 to determine if it can slow the progression of Progressive Supranuclear Palsy (PSP), a rare brain disorder affecting movement and balance. Participants will receive either FNP-223 or a placebo (a harmless pill with no active drug) to compare outcomes. The trial aims to evaluate FNP-223's effectiveness over a year and assess its safety and manageability for people with PSP. Individuals with PSP symptoms for three years or less, who experience balance issues or eye movement problems, may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important PSP advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that FNP-223 is likely to be safe for humans?

Research has shown that FNP-223 has been studied for its safety in humans. This treatment is a pill designed to help with Progressive Supranuclear Palsy (PSP), a brain disorder. In earlier studies, patients who took FNP-223 showed a decrease in tau protein buildup, which is linked to better brain function.

While specific safety details aren't provided, this trial is in the second phase. Phase 2 trials usually indicate that the treatment has shown some safety in earlier tests. This phase focuses on how well patients handle the drug and its side effects. So far, ongoing studies suggest that researchers are carefully checking FNP-223 for safety. Participants in the trial take the treatment three times a day for 52 weeks as part of the safety evaluation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for progressive supranuclear palsy (PSP) focus on managing symptoms, often through medications like levodopa or amantadine, which aim to improve movement and control. However, FNP-223 is unique because it targets the underlying mechanisms of PSP rather than just alleviating symptoms. Researchers are excited about FNP-223 because it offers a novel approach by potentially modulating specific pathways involved in the disease progression, which could slow down or alter the course of PSP. This represents a significant shift from current treatments, which primarily address only the symptoms without affecting the disease's progression.

What evidence suggests that FNP-223 might be an effective treatment for PSP?

Studies have shown that FNP-223, which participants in this trial may receive, may help reduce tau protein buildup linked to progressive supranuclear palsy (PSP). Reports indicate that this treatment improves movement and breathing, major issues in PSP. Research suggests that FNP-223 aims to slow the disease's progression by targeting these brain changes. Although still under study, these early findings offer hope for better managing PSP symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with Progressive Supranuclear Palsy (PSP), who've had symptoms like difficulty moving their eyes or frequent falls within the first three years of onset. They should weigh between 95 and 265 lbs, be able to walk at least ten steps with minimal help, not live in a nursing facility, and have a caregiver.

Inclusion Criteria

Has a caregiver or study partner who will accompany them to the study visits. The caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant's medication and overall condition. Prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (IEC)/institutional review board (IRB) approved informed consent

Reside outside a skilled nursing facility or dementia care facility

My weight is between 95 and 265 lbs.

Exclusion Criteria

Score of 3 on any functional domain in the PSP-CDS

I do not have PSP-RS movement disorders or other CNS diseases.

I have a known genetic mutation based on my family or medical history.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FNP-223 or placebo orally, 3 times daily for 52 weeks

52 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FNP-223

Trial Overview The PROSPER trial is testing FNP-223's ability to slow down PSP progression compared to a placebo. Participants will be evaluated using the PSP Rating Scale over one year while also monitoring the safety and effects of FNP-223 on their bodies.

How Is the Trial Designed?

Group I: FNP-223 Experimental Treatment 1 Intervention

Participants will receive FNP-223 orally (PO), 3 times daily (TID).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo, PO, TID.

Who Is Running the Clinical Trial?

Ferrer Internacional S.A.

Lead Sponsor

Trials

27

Recruited

11,700+

Published Research Related to This Trial

The use of F-THK5351 PET imaging in a 71-year-old man diagnosed with probable progressive supranuclear palsy (PSP) demonstrates the potential of new tau-PET ligands to visualize tau-protein distribution, which is linked to neurodegeneration in PSP.

This imaging technique may improve the diagnosis of PSP, which is often underdiagnosed due to its symptoms overlapping with other conditions, by providing clearer insights into the presence and progression of tau-protein aggregates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Added Value of Tau-PET in the Assessment of Progressive Supranuclear Palsy. López-Mora, DA., Fernández León, A., Lleó, A., et al.[2021]

The study involved 15 patients with progressive supranuclear palsy (PSP) who underwent [18F]FDDNP PET scanning, revealing that this imaging probe effectively visualizes tau fibrillar aggregates in the brain, particularly in subcortical areas, regardless of disease severity.

[18F]FDDNP PET imaging demonstrated distinct binding patterns in PSP patients compared to controls and those with Parkinson's disease, suggesting its potential as a diagnostic tool and a biomarker for monitoring tau pathology progression and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET imaging of neuropathology in tauopathies: progressive supranuclear palsy. Kepe, V., Bordelon, Y., Boxer, A., et al.[2021]

In a study of 17 patients with progressive supranuclear palsy (PSP), increased uptake of the 18F-THK5351 PET tracer was observed in specific brain regions, such as the globus pallidus and red nucleus, indicating a potential biomarker for diagnosing PSP.

Higher levels of tracer uptake were associated with more severe symptoms, such as oculomotor dysfunction and postural instability, suggesting that 18F-THK5351 PET imaging can enhance diagnostic certainty and correlate with the severity of PSP symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-THK5351 PET imaging in patients with progressive supranuclear palsy: associations with core domains and diagnostic certainty. Hsu, JL., Chen, SH., Hsiao, IT., et al.[2021]

The age-adjusted prevalence of progressive supranuclear palsy (PSP) was found to be 2.95 cases per 100,000 people in 2016, which is lower than previously reported figures in other studies.

Common symptoms such as gait abnormalities, joint pain, and fatigue were frequently observed in patients up to five years before their official diagnosis, suggesting that earlier identification of PSP could be improved by recognizing these antecedent conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Features of Patients With Progressive Supranuclear Palsy in an US Insurance Claims Database. Viscidi, E., Litvan, I., Dam, T., et al.[2021]

In a study involving 187 patients with progressive supranuclear palsy (PSP), the PSP-Rating Scale was identified as the most efficient measure for detecting significant changes in disease progression, requiring only 51 patients per group for a 50% change over one year.

The study found no detectable placebo effect on the PSP-Rating Scale or the Schwab and England Activities of Daily Living, suggesting that these scales can reliably assess treatment efficacy in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Power calculations and placebo effect for future clinical trials in progressive supranuclear palsy. Stamelou, M., Schöpe, J., Wagenpfeil, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06355531

NCT06355531 | A Study to Assess the Efficacy, Safety, and ... PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale ...

2. psptrialferrer.com psptrialferrer.com/

Study Prosper The PROSPER Study aims to assess how safe and effective a study medicine called FNP-223 may be in treating progressive supranuclear palsy (PSP).

3. neurologyadvisor.com neurologyadvisor.com/news/oral-oga-inhibitor-fast-tracked-for-progressive-supranuclear-palsy/

Oral OGA Inhibitor Fast Tracked for Progressive ... Findings showed that oral administration of FNP-223 reduced tau pathology (NFT formation), improved motor and breathing function, and increased ...

4. ferrer.com ferrer.com/en/Ferrer-advances-research-Progressive-Supranuclear-Palsy-PSP

Ferrer advances research into Progressive Supranuclear ... 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06355531?cond=%22progressive%20supranuclear%20palsy%22&viewType=Table&rank=3

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

6. clinicaltrials.eu clinicaltrials.eu/inn/fnp-223/

FNP-223: A Promising Drug for Progressive Supranuclear ... This double-blind, placebo-controlled Phase 2 study aims to assess the efficacy, safety, and pharmacokinetics of FNP-223 over a 52-week period. The trial ...

7. app.trialscreen.org app.trialscreen.org/trials/phase-2-to-assess-efficacy-safety-pharmacokinetics-fnp-223-slow-progression-trial-nct06355531

A Study to Assess the Efficacy, Safety, and ... - TrialScreen The primary goal of this study is to evaluate the effectiveness of an investigational drug called FNP-223 in slowing the progression of Progressive ...