Active Brain & Nervous System NIHR-supported project Lungs & Breathing

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)

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Southampton Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Jun 2027

In plain English

AI plain-English summary

A drug candidate called FNP-223 is being tested in 220 people with progressive supranuclear palsy (PSP) to see if it can slow the disease’s relentless progression. PSP is a rare, fatal brain disorder that gradually destroys a person’s ability to walk, speak, swallow, and control eye movements. There are currently no treatments that slow or stop the disease—only therapies that manage symptoms temporarily. This Phase 2 trial is one of the first rigorous tests of a drug designed to target the underlying biological process, likely the abnormal clumping of a protein called tau in brain cells. If FNP-223 proves safe and effective, it would be the first disease-modifying therapy for PSP. That would change the outlook for patients and their families, offering years of preserved mobility and independence rather than a steady decline. It would also provide a proof-of-concept for tau-targeting drugs in other neurodegenerative diseases, such as Alzheimer’s, where tau pathology also plays a central role. The trial’s results will determine whether the drug moves into larger Phase 3 studies.

View original technical description
This study is a Phase 2 a randomized, double-blind, placebo-controlled study which will be conducted in approximately 220 male and female adult participants with progressive supranuclear palsy (PSP). Participants with either be randomised to receive the study medication FNP-223 or the placebo to be taken orally three times a day.The study will consist of a Screening Phase lasting up to 42 days during which participants will be assessed for eligibility, a Treatment Phase consisting of 52 weeks treatment and a 4 week follow up period.Participants will undergo site visits (Visit 1/Week 0/Day 1), Week 4 (Visit 3), Week 16 (Visit 6), Week 28 (Visit 8), Week 40 (Visit 10), and Week 52 (Visit 12). On Week 2 (Visit 2), Week 8 (Visit 4), Week 12 (Visit 5), Week 22 (Visit 7), Week 34 (Visit 9), Week 46 (Visit 11), and follow up on Week 56 (Visit 13), visit will be conducted telephonically.During the course of the study, participants will undergo a number of different procedures including blood sampling, ECGs, MRIs (optional), Neurological and physical examinations and assessment of balance. Participants will be invited to consent to 2 optional lumbar punctures to collect Cerebrospinal fluid (CSF) at Visit 1 and Visit 8 or Visit 12. 4 mL of CSF would be collected per extraction. Prior to their consent, the study doctor access the participants to confirm if they are eligible to provide the CSF sample.

Researchers

Boyd Gosh (Principal Investigator)

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