GemVax Completes Patient Dosing for Global Phase 2 Alzheimer's Trial

GemVax & KAEL announced on April 28 that it has successfully completed patient dosing for the global Phase 2 clinical trial of its Alzheimer's disease treatment, GV1001.

The global Phase 2 clinical trial of GV1001 began with the first patient enrollment in the United States in October 2022, and dosing was conducted at 43 institutions across seven countries in the United States and Europe. The company aims to announce the final results within this year.

In the clinical trial, 199 patients with mild to moderate Alzheimer's disease received subcutaneous injections of either 0.56mg or 1.12mg of GV1001 for 50 weeks. The study is evaluating the efficacy and safety of GV1001 compared to placebo.

GemVax previously demonstrated the efficacy and safety of GV1001 in a Phase 2 clinical trial conducted in Korea. In that study, patients with moderate to severe Alzheimer's disease received GV1001 for six months, and showed significant improvement in key assessment indicators, such as the Severe Impairment Battery (SIB) score, compared to the control group. In the high-dose group, the decrease in SIB scores was significantly smaller, indicating a meaningful improvement compared to the control group.

GV1001 is a multi-target drug that simultaneously exhibits various effects, including antioxidant activity, mitochondrial protection, and improvement of the brain's immune environment. Mechanistic studies on Alzheimer's disease have confirmed that GV1001 specifically acts on microglia and astrocytes, which are representative non-neuronal cells that play a major role in neuroinflammation, thereby alleviating neuroinflammation in the brain.

A GemVax official stated, "Successfully completing patient dosing as planned in the global Phase 2 clinical trial, in collaboration with institutions in several countries in the United States and Europe, is a very meaningful step forward. We will thoroughly analyze the data going forward and do our utmost to demonstrate the efficacy and safety of GV1001 for Alzheimer's disease in the global clinical trial as well."

GemVax has also completed the first-ever Phase 2 clinical trial in Korea for progressive supranuclear palsy (PSP), another neurodegenerative disease. The trial results confirmed tolerability and a trend toward slowing disease progression, and based on these findings, the company is preparing for a global Phase 3 clinical trial.

An extension clinical trial is currently underway, in which patients who completed the domestic Phase 2 clinical trial (six months of dosing) are receiving an additional 12 months of treatment. Through this extension trial, GemVax will further assess the long-term efficacy and safety of 18 months of GV1001 administration.