Meta-Analysis Data of VIVIAD and VIVA-MIND Studies at ERA 2025

Halle (Saale) / Munich, Germany, June 6, 2025 – Breaking new ground in the fight against kidney diseases, Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) has presented compelling meta-analysis data of its ongoing VIVIAD and VIVA-MIND studies at the 62nd ERA Congress of the European Renal Association in Vienna, Austria. The data centers on the company’s lead drug in development, varoglutamstat, and its significant impact on kidney function.

In a world where kidney diseases continue to escalate, Vivoryon’s dedication to developing small molecule medicines, especially for inflammatory and fibrotic disorders, is not just commendable but crucial. The company’s focus on the kidney space, in particular, puts them at the forefront of a much-needed medical revolution.

CEO Frank Weber, MD, expressed his delight at the opportunity to share the breakthroughs witnessed in the Phase 2 program at the ERA 2025 congress. Weber noted that the outstanding improvements of varoglutamstat on kidney function, specifically eGFR, highlighted Vivoryon’s commitment to delivering innovative solutions in the kidney space.

Varoglutamstat, a first-in-class glutaminyl cyclase (QPCT/L) inhibitor, has shown potent anti-inflammatory and anti-fibrotic effects. The VIVIAD and VIVA-MIND studies, conducted independently in the EU and U.S, displayed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. The consistency of this improvement across both trials, replicated in the meta-analysis and pooled analysis, solidifies the evidence supporting varoglutamstat’s efficacy.

Remarkably, the meta-analysis confirmed a substantially larger effect size in study participants with diabetes compared to those without. This underlines the potential of varoglutamstat in managing diabetic kidney disease – a major concern in today’s aging population.

With these promising results, Vivoryon is set to embark on a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The primary aim will be to investigate the efficacy of varoglutamstat on eGFR in this patient population and obtain additional information on a potential effect on proteinuria and other kidney-specific markers.

The presentation of the meta-analysis data at the ERA Congress marks a significant milestone in Vivoryon’s journey and the broader biotech industry. As the company continues to pave the way in developing groundbreaking therapies for kidney diseases, the global medical community watches with anticipation. The potential of varoglutamstat, as demonstrated in the VIVIAD and VIVA-MIND studies, sets the stage for a new era in the treatment of kidney diseases.

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