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 Clinical Trials in the U.S. and 7 European Countries

– Targeting Completion in the First Half of Next Year

GemVax & KAEL Co., Ltd. (GemVax, 082270) announced on the 12th that it has successfully completed patient recruitment for the global Phase 2 clinical trial of GV1001, its drug for treating Alzheimer’s disease.

A total of 199 patients have been enrolled in the trial—83 in the United States and 116 across seven European countries, including Spain, the Netherlands, and Poland. The study is evaluating the efficacy and safety of GV1001 administered subcutaneously at doses of 0.56 mg or 1.12 mg over a 53-week period (12 months) in patients with mild to moderate Alzheimer’s disease. The primary efficacy measure is the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog).

Having received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), GemVax is conducting the trial at 43 institutions across the U.S. and Europe.

Alzheimer’s disease, the most common neurodegenerative disease causing dementia, disrupts communication between nerve and glial cells, leading to inflammation, brain cell death, and a decline in nerve cell function. This progressive damage ultimately results in the loss of all daily life functions. While recent treatments have been developed to slow disease progression and improve cognitive function, they often come with significant side effects, leaving a high unmet need for safer therapies.

GV1001 has demonstrated no significant side effects or adverse reactions to date and has shown potential as a multi-mechanism treatment for Alzheimer’s disease. It inhibits the deposition of beta-amyloid and the aggregation of tau protein in nerve cells. Moreover, recent studies have identified a novel mechanism by which GV1001 regulates microglia and astrocytes through its interaction with the gonadotropin-releasing hormone receptor (GnRHR), adding further therapeutic potential.

A GemVax official stated, “Despite initial challenges in launching this global Phase 2 clinical trial across eight countries, including the U.S., we are progressing smoothly and have successfully completed patient recruitment. We remain fully committed to ensuring that all patients complete treatment and look forward to delivering final results that could help develop a safe and effective treatment for Alzheimer’s disease.”

In addition to its Alzheimer’s program, GemVax is developing a treatment for progressive supranuclear palsy (PSP), another neurodegenerative and rare disease. The company’s domestic Phase 2 clinical trial for PSP has already completed patient recruitment, with full dosing expected by year-end. GemVax has also received FDA approval for its PSP Phase 2 clinical trial plan and is preparing to submit clinical trial applications in the UK and Europe as part of its global drug development efforts.

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