A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)

Ferrer

Status and phase: Enrolling; Phase 2

Conditions: Progressive Supranuclear Palsy

Treatments: Drug: FNP-223; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06355531

FNP223-CT-2301

Details and patient eligibility

About

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 (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP.

Enrollment: 220 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants aged 50 to 80 years, inclusive, at the time of informed consent.

• Diagnosis of possible or probable PSP of the Richardson's Syndrome (PSP-RS) phenotypes according to the Movement Disorders Society's Progressive Supranuclear Palsy (MDS PSP) clinical features criteria. At least 1 (either 1 or both) of the following 2 items must be met:

  1. Vertical supranuclear gaze palsy.
  2. Slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms.

• Presence of PSP symptoms within ≤3 years prior to screening.

• MoCA score ≥23

• Full 28-item PSPRS score ≤40.

• Able to ambulate independently or with minimal assistance defined as the ability to take at least 10 steps (stabilization of 1 arm [ie, use of cane]).

• Body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs.

• Reside outside a skilled nursing facility or dementia care facility, except for participants residing in an assisted living facility.

• 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.

Exclusion criteria

Non-PSP- RS Movement Disorders or other central nervous system (CNS) Diseases

• Score of 3 on any functional domain in the PSP-CDS.
• Participants with known PSP genetic mutation (based on familiar or clinical history).
• Evidence of other neurological disorder that could explain signs of PSP (eg, Parkinson's disease, Alzheimer disease, etc.).
• Brain magnetic resonance imaging (MRI) within 1 year of screening consistent with:
• Primary degenerative diseases other than PSP.

Procedures

• For the optional substudy only: Contraindication or refusal to undergo 2 lumbar punctures for obtaining CSF.
• Contraindication or inability to tolerate MRI for screening MRI and volumetric brain MRI assessments throughout the substudy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

220 participants in 2 patient groups, including a placebo group

FNP-223

Experimental group

Description:

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

Treatment:

Drug: FNP-223

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo, PO, TID.

Treatment:

Drug: Placebo