GemVax&Kael announced on the 18th that it submitted the clinical phase 2 trial plan (IND) for the progressive supranuclear palsy (PSP) treatment 'GV1001' to the U.S. Food and Drug Administration (FDA) on the 15th (local time).
This clinical trial will be conducted to evaluate the efficacy and safety of subcutaneous administration of GV1001 at doses of 0.56 mg or 1.12 mg over 12 months in 150 PSP patients. The trial is expected to be carried out at approximately 30 to 40 institutions. The primary efficacy endpoint is set as the total score change in the PSP Rating Scale (mPSPRS) after 12 months of GV1001 administration compared to baseline.
PSP is an atypical Parkinsonian syndrome characterized by a rapid progression of the disease, making it the most severe form among Parkinsonian disorders. There is currently no fundamental treatment for this disease. Accordingly, GemVax also received IND approval from the Ministry of Food and Drug Safety in Korea last March and is conducting the first domestic phase 2 clinical trial for PSP. Additionally, the company is preparing to submit an IND for the PSP phase 2 trial to the European Medicines Agency (EMA).
A GemVax representative stated, “While the phase 2 clinical trials for Alzheimer's disease in the U.S. and Europe are progressing smoothly, we aim to challenge global clinical trials for the rare disease PSP as well, thereby increasing the global commercialization potential of the 'neurodegenerative disease treatment GV1001.'”
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