On 9 December, Vivoryon Therapeutics N.V., a clinical stage biotechnology company focused on developing innovative small molecule-based medicines, announced topline data from its Phase II VIVA-MIND study evaluating varoglutamstat in people with early Alzheimer’s disease (AD). The trial, conducted in the US, aimed to assess the safety and efficacy of varoglutamstat, a 600mg twice-daily dose, over 18 months. The study was discontinued early following negative results from a parallel European Phase IIb trial, VIVIAD, which missed all of its endpoints in March 2024. The VIVA-MIND study, originally planned to enroll a total of 414 participants, ultimately enrolled 112 randomised participants, with 109 receiving treatments in the Phase IIa portion, which focused on adaptive dose-finding.
Similar to the VIVIAD study, VIVA-MIND failed to meet its primary endpoint of measuring clinically meaningful and statistically significant differences, assessed through Clinical Dementia Rating – Sum of Boxes (CDR-SB) scores. The study also did not achieve its key secondary endpoints, including Cognitive Function Composite 2 (CFC2) and Alzheimer's Disease Assessment Schedule-Cognitive Subscale (ADAS-Cog) 13. However, varoglutamstat demonstrated a favorable safety and tolerability profile in VIVA-MIND with no new safety signals detected. In addition, the study revelated a statistically significant improvement in kidney function in participants treated with varoglutamstat compared to those on placebo, reinforcing similar findings from the completed VIVIAD study. This data supports the company’s development strategy to advance into a Phase II study in diabetic kidney disease.