GemVax Applies for FDA IND for Phase 2 Clinical Trial of Progressive Supranuclear Palsy Treatment

GemVax & Kael announced on the 18th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial of 'GV1001,' a treatment for progressive supranuclear palsy (PSP).

GemVax plans to evaluate the efficacy and safety of the drug by administering 0.56 mg or 1.12 mg of GV1001 to 150 PSP patients across 30 to 40 institutions over 12 months. The primary efficacy endpoint is the change in the total score of the PSP Rating Scale (mPSPRS) after 12 months of GV1001 treatment compared to baseline.

PSP is an atypical Parkinsonian syndrome characterized by rapid disease progression, making it one of the most severe forms of Parkinsonism. GemVax is currently conducting a Phase 2 clinical trial of GV1001 in South Korea. Following the FDA submission, the company is also preparing to apply for a Phase 2 trial with 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, by challenging global clinical trials for the rare disease PSP, we have increased the global commercialization potential of GV1001 as a treatment for neurodegenerative diseases."

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