GemVax Receives Approval for Phase 2 Clinical Trial Plan of Progressive Supranuclear Palsy Treatment

GemVax & Kael announced on the 7th that it received approval from the Ministry of Food and Drug Safety on the 6th for the domestic Phase 2 clinical trial plan (IND) of GV1001, a treatment for progressive supranuclear palsy (PSP).

The clinical trials will be conducted at Seoul National University Boramae Medical Center, Seoul National University Hospital, Bundang Seoul National University Hospital, Samsung Medical Center, and Kyung Hee University Hospital.

PSP is an atypical Parkinsonian syndrome and is the most severe form among Parkinsonian disorders. The disease progresses rapidly and currently has no fundamental treatment. Symptoms include gait disturbance, postural instability, cognitive decline, ocular motor dysfunction, and sleep disorders.

GV1001, which received clinical trial approval as a PSP treatment, is the same drug that GemVax achieved successful results with in a Phase 2 clinical trial for Alzheimer's disease. GemVax conducted preclinical studies based on the possibility that GV1001 could also be effective in treating PSP. Animal experiments showed statistically significant efficacy in improving motor function and spatial cognitive ability, as well as inhibiting tau protein damage.

A GemVax representative stated, "Following the Phase 2 clinical trial for Alzheimer's disease, we plan to expand the application scope of GV1001 to neurodegenerative diseases in general by conducting the Phase 2 clinical trial for PSP." They added, "This marks the conclusion of the direction of GV1001, which has been researched for over 15 years," and "It clearly expresses our determination to become a leader in the neurodegenerative disease market."

The estimated number of PSP patients is about 20,000 in the United States and approximately 260,000 across 16 major countries. Since PSP is a representative difficult-to-treat atypical Parkinsonian syndrome, success in the Phase 2 clinical trial is expected to bring us closer to conquering Parkinsonian syndromes.

Professor Lee Ji-young, head of the clinical trial and a neurologist at Seoul National University College of Medicine, said, "The significance of this clinical trial lies in it being the first clinical trial for PSP, a refractory Parkinsonian syndrome, in Korea." She added, "We will focus on confirming the safety and development potential of GV1001, which is the primary goal of this initial Phase 2 clinical trial."

This content was produced with the assistance of AI translation services.