GemVax Completes Patient Enrollment for Global Phase 2 Trial of Alzheimer's Disease Treatment

GemVax & Kael announced on the 12th that it has completed patient recruitment for the global Phase 2 clinical trial of GV1001, a treatment for Alzheimer's disease.

A total of 199 patients were enrolled, with 83 in the United States and 116 in Europe. The trial targets patients with mild to moderate Alzheimer's disease, administering GV1001 at doses of 0.56mg or 1.12mg via subcutaneous injection for 53 weeks (12 months) to evaluate the efficacy and safety of GV1001. The primary efficacy endpoint is the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog).

GemVax received approval for the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) and expanded the clinical trial to seven European countries including Spain, the Netherlands, and Poland. The Phase 2 clinical trial is being conducted at a total of 43 institutions across the U.S. and Europe.

GemVax's GV1001 has shown no adverse effects or abnormal reactions to date and has been confirmed to have various mechanisms of action for treating Alzheimer's disease, such as inhibiting beta-amyloid deposition and tau protein aggregation in nerve cells. Recent studies have demonstrated a mechanism by which GV1001 binds to the gonadotropin-releasing hormone receptor (GnRHR) and directly regulates microglia and astrocytes.

A GemVax representative stated, "With patient recruitment completed, the clinical trial is progressing smoothly," adding, "We will do our best until all patients have completed dosing and the final results are available to develop a safe and fundamental treatment for Alzheimer's disease."

GemVax is also developing a treatment for Progressive Supranuclear Palsy (PSP), a rare neurodegenerative disease. Patient recruitment for the Phase 2 clinical trial, which is also the first of its kind in Korea, has been completed, and dosing is expected to be completed within the year. The company received IND approval for the PSP Phase 2 clinical trial from the U.S. FDA, marking the start of global new drug development. Applications for clinical trials are also being prepared in the UK and Europe.