GemVax to Announce Global Phase 2 Results for Alzheimer's Disease in Early November

GemVax & KAEL will announce the results of its global Phase 2 clinical trial for Alzheimer's disease in early November.

On October 24, GemVax stated that it expects to receive the final Clinical Study Report (CSR) for its Phase 2 Alzheimer's disease trial, conducted across seven countries in the United States and Europe, within the next two weeks.

The clinical trial began enrolling its first patient in the United States in October 2022 and was conducted at 43 sites across the United States and seven European countries. The study administered subcutaneous injections of GV1001 at doses of 0.56mg, 1.12mg, or placebo for 50 weeks to 199 patients with mild to moderate Alzheimer's disease. Efficacy was assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog11), Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q), Clinical Dementia Rating-Sum of Boxes (CDR-SB), and Quality of Life in Alzheimer's Disease (QoL-AD) questionnaire, along with safety evaluations.

Previously, GemVax had confirmed the therapeutic potential of GV1001 through a Phase 2 clinical trial conducted in Korea. At that time, the drug was administered for six months to patients with moderate to severe Alzheimer's disease. The results showed significant improvement in key indicators, such as the Severe Impairment Battery (SIB), compared to the placebo group. No serious adverse events or abnormal reactions related to GV1001 were reported, confirming its safety profile.

A GemVax representative commented, "This clinical trial was conducted with more than twice the treatment duration and patient enrollment compared to the Phase 2 trial carried out in Korea, and it has been successfully completed. Only the confirmation of the final results remains." The representative added, "We hope to see meaningful results in the development of treatments for Alzheimer's disease, where there is still a significant unmet medical need."

GV1001 is a peptide-based drug candidate that inhibits the accumulation of beta-amyloid and the aggregation of tau protein in nerve cells, and simultaneously exhibits various effects such as anti-inflammatory, antioxidant, and mitochondrial protective actions.