GemVax&Kael said the Ministry of Food and Drug Safety approved its phase 2 clinical trial plan (IND) of GV1001, a progressive supranuclear palsy (PSP) treatment, on Monday.
The company will conduct the clinical trial at domestic hospitals, including Seoul National University Borame Medical Center.
PSP is a non-typical Parkinson's syndrome and is the most serious of Parkinson's disease, which progresses quickly with no fundamental treatment. Primary symptoms include gait disorders, posture instability, cognitive decline, eye movement disorders, and sleep disorders.
The cause of the disease is not yet known. Still, there are pathophysiological similarities to Alzheimer's disease, such as inflammation of brain neurons and neuronal cell death due to damage to tau proteins. GV1001, which was recently approved for clinical trials as a PSP treatment, has already produced successful results in phase 2 clinical trials for Alzheimer's disease.
GV1001 previously showed statistically significant efficacy in restoring motor ability, spatial cognitive ability, and inhibiting damage to tau protein in animal experiments.
GV1001 combines peptides derived from the human enzyme telomerase and is known to have anti-aging, antioxidant, and anti-inflammatory effects. It is a multi-faceted drug candidate expected to improve the brain's immune environment and reduce inflammation in neurodegenerative diseases such as Alzheimer's and PSP.
There are about 20,000 PSP patients in the U.S. and 260,000 more in 16 other countries. PSP is a representative disease difficult to treat among non-typical Parkinson's syndrome, so the phase 2 clinical trial results are eagerly anticipated.
“This is the first clinical trial in Korea for PSP, an intractable Parkinson's syndrome,” said Professor Lee Ji-young of neurology at Seoul National University Boramae Medical Center. “As this is an early phase clinical trial in PSP patients, it will focus on confirming the safety and development potential of GV1001."
A GemVax official said, "We plan to expand the scope of GV1001 for neurodegenerative diseases by conducting clinical trials for Alzheimer's disease and PSP simultaneously. GemVax remains committed to leading the growing neurodegenerative disease market."