On 30 March, GemVax&KAEL, an innovative global bio company developing new drugs for diseases such as Alzheimer’s disease (AD), announced that it completed the first participant registration for its Phase II AD clinical trial of GV1001 in Spain. GV1001’s global clinical trial was first registered in the US in October 2022. So far, the company has enrolled six participants and recently received approval in Europe. The multicenter, randomised, double-blind and placebo-controlled Phase II study plans to recruit 180 participants with mild to moderate AD in US and 7 EU countries, who will receive either four weekly subcutaneous injections of GV1001 (0.56 or 1.12 mg) or placebo, followed by biweekly injections for one year. The primary outcome will be the change on ADAS-Cog, a widely accepted performance-based assessment of cognition used in clinical studies for the treatment of people with AD. The completion of the study is anticipated in September 2024.
https://www.koreabiomed.com/news/articleView.html?idxno=20593
