Vivoryon Therapeutics N.V. presented compelling meta-analysis data from its Phase 2 program for varoglutamstat at the 62nd ERA Congress of the European Renal Association in Vienna, demonstrating sustained improvements in kidney function that could represent a breakthrough for diabetic kidney disease treatment.
The meta-analysis combined results from VIVIAD and VIVA-MIND, two independent Phase 2 studies conducted in the EU and U.S., showing that varoglutamstat achieved statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) in an elderly patient population. The improvement was consistent across both trials independently and replicated in both meta-analysis and pooled analysis, providing converging evidence for the drug's efficacy.
Sustained Efficacy Profile
The data revealed that statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96, demonstrating the drug's durable therapeutic effect. Notably, the meta-analysis confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes, highlighting the drug's particular promise for diabetic kidney disease.
"We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space," said Frank Weber, MD, CEO of Vivoryon.
Novel Mechanism of Action
Varoglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. The drug represents an innovative approach to treating kidney diseases by modulating the activity and stability of pathologically relevant proteins, addressing both inflammatory and fibrotic components of kidney disease progression.
Next Steps in Development
Based on the encouraging results, particularly the enhanced efficacy observed in diabetic patients, Vivoryon plans to initiate a dedicated Phase 2b trial in patients with diabetic kidney disease, specifically targeting patients with diabetes and chronic kidney disease stage 3b/4. The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on potential effects on proteinuria and other kidney-specific markers.
The presentation, titled "Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studies," was delivered by CEO Frank Weber during a focused oral session at the congress.
Vivoryon is a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. The company's proprietary, first-in-class orally available QPCT/L inhibitor varoglutamstat represents its most advanced program in the pursuit of improving patient outcomes for severe kidney diseases.
