GV1001 by GemVax (Photo by GemVax)
[Asia Economy Reporter Lee Chun-hee] GemVax & Kael (GemVax) announced on the 29th that it has applied to the Ministry of Food and Drug Safety for approval of the domestic Phase 2a clinical trial plan (IND) for 'GV1001,' a treatment for progressive supranuclear palsy (PSP).
This clinical trial will be conducted to evaluate the efficacy in improving disease severity and safety by subcutaneously administering GV1001 at doses of 0.56 mg or 1.12 mg to PSP patients. It is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-design, prospective clinical trial. The trial will be conducted over six months with 75 patients at four domestic hospitals, including Seoul National University Boramae Medical Center. The primary efficacy endpoint is the change in the total score of the PSP rating scale after six months of GV1001 administration compared to baseline.
PSP is a type of atypical Parkinsonian syndrome, a neurodegenerative disease. It includes diseases that show symptoms similar to Parkinson's disease along with additional symptoms, such as PSP, multiple system atrophy, corticobasal degeneration, and Lewy body dementia. Among these, PSP is known to be the most malignant, and its cause has not been clearly identified, so there is currently no treatment available.
GemVax has conducted research for over three years before applying for the PSP Phase 2 clinical trial. They confirmed symptom improvement in patients through the compassionate use approval (emergency clinical) system. GV1001 previously secured effective data in a Phase 2 trial for Alzheimer's dementia and demonstrated efficacy in preclinical trials. GV1001 showed equivalent or statistically significant efficacy compared to control substances in motor function, spatial cognition, and novel object recognition tests. Brain tissue analysis confirmed the inhibitory effect on tau hyperphosphorylation in major brain lesion areas of PSP.
The estimated number of PSP patients is about 20,000 in the United States alone and approximately 260,000 worldwide. Since there is no approved treatment globally, if therapeutic efficacy is proven, it could become the first-in-class new drug in its category. Additionally, as PSP is the most malignant form of Parkinson's disease, it may open possibilities for conquering Parkinson's disease.
A GemVax official stated, “PSP progresses about three times faster and causes more severe disability than neurodegenerative diseases like Alzheimer's or Parkinson's disease, yet there is no treatment, making drug development urgent. Based on experimental evidence from preclinical trials and the results of the preceding domestic Alzheimer's Phase 2 trial, we expect to confirm meaningful effects in this PSP clinical trial.”
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