GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP)

NCT05819658 | Completed Phase 2 Results

• 1 other identifier: GV1001-PSP-CL2-011
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

The study will be conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy, (PSP). In 75 patients diagnosed with PSPR Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) at five hospitals in Korea, subcutaneous administration of GV1001 0.56 or 1.12 mg/day will be conducted with multicenter, randomized, double-blind, placebo-controlled, parallel design, prospective phase 2a.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy; GV1001

Outcome Measures

Primary Outcomes (1)

• Change From the Baseline in the Total Score of PSP-rating Scale

  Change from the baseline in the total score of PSP-rating scale(Progressive Supranuclear Palsy Rating Scale) after 24 weeks (6 months) of investigational product administration. The possible total scores range from 0 to 100 with a higher score indicating severely impaired cognitive function.

  24 weeks(6 months)

Secondary Outcomes (21)

• Change From the Baseline in the Total Score of PSP-rating Scale

  12 Weeks(3 months)

• Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

  12 weeks (3 Months)

• Change From the Baseline in the Montreal Cognitive Assessment - Korea (MoCAK)

  24 weeks(6 months)

• Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

  12 weeks(3 months)

• Change From the Baseline in the Korean Frontal Assessment Battery (K-FAB)

  24 weeks(6 months)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

Drug: GV1001 Placebo

GV1001 0.56 mg

EXPERIMENTAL

GV1001 0.56 mg SC injection will be administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

Drug: GV1001 0.56mg

GV1001 1.12 mg

EXPERIMENTAL

GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24 for double blind phase.

Drug: GV1001 1.12mg

Interventions

GV1001 Placebo DRUG

0.9% normal saline

Also known as: Normal saline

Placebo

GV1001 0.56mg DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide 0.84mg

GV1001 0.56 mg

GV1001 1.12mg DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide 1.68mg

GV1001 1.12 mg

Eligibility Criteria

• Age: 41 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥41 years to ≤ 85 years.
• Clinical diagnosis of probable progressive supranuclear palsy (PSP).
• Patient is on a stable therapy for a neurological drug for at least 1 month prior to screening visit.
• Patients who are able to walk 3 meters or more independently or with assistive devices.
• Score 15 points ≥ on the Korean Mini-Mental Status Exam (K-MMSE) at the screening visit.
• Have reliable caregiver to accompany participant to all study visits.
• Patients and/or their representatives who have voluntarily provided a written consent for participation in this clinical study.

You may not qualify if:

• Patients who have Presence of structural lesions or Suspected concurrent onset of central nervous system diseases based on the CT/MRI scan results and neurological examinations performed within 12 months of screening or at screening.
• Patients with a history of known or suspected seizures.
• Patients with a recent unexplained loss of consciousness within 3 months prior to screening or a history of significant head trauma with loss of consciousness.
• Patients with acute or unstable cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes, or any other medical condition that can interfere with completing the clinical study.
• Patients with hypersensitivity reactions to the ingredients of the investigational product.
• Patients with a history of cancer within 5 years prior to screening.
• Patients with abnormal renal function.
• Patients with severe liver function abnormalities.
• Patients weighing ≤35 kg.
• Among the female subjects who does not agree to use proper contraception.
• Pregnant or breastfeeding women.
• Patients who participated in another clinical study within 4 weeks prior to screening and were administered investigational products or were applied investigational medical devices.
• Patients who were administered the study drug (GV1001) of this clinical study within 12 months prior to screening.
• Patients who participated in a clinical study for progressive supranuclear palsy within 6 months prior to screening.
• Other patients judged by the investigator as ineligible to participate in this clinical study.

Sponsors & Collaborators

• GemVax & Kael: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Hyuck Lee, Clinical Research Manager
• Organization: GemVax & Kael

leehyuck@gemvax.com

+82 070 8633 6925

Study Officials

• Sang Jae Kim

  GemVax & Kael

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: June 14, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)