Vivoryon Therapeutics Reveals New Data on Varoglutamstat's Impact on Diabetic Kidney Function and Development Plan

Vivoryon Therapeutics N.V. has unveiled new data highlighting the significant treatment effects of its investigational drug, varoglutamstat, on kidney function in patients with diabetes. The findings, derived from a subgroup analysis in the VIVIAD Phase 2b study, demonstrate a notable improvement in estimated glomerular filtration rate (eGFR) among diabetic patients, reinforcing previous results observed in the broader study population. 

The Phase 2b study, initially focused on Alzheimer's disease, revealed that diabetic patients treated with varoglutamstat experienced an eGFR increase of more than 8 mL/min/1.73m²/year (p=0.02) compared to a 3.4 mL/min/1.73m²/year improvement in the overall study population (p<0.001). This substantial treatment effect in the diabetes subgroup is complemented by additional health benefits, including reductions in liver transaminases, minor weight loss, and lower diastolic blood pressure. These effects were observed over 48 weeks of treatment and were not apparent in the placebo group or the broader study population.

The analysis further highlighted that the improvement in kidney function appears to be independent of glycemic control, as HbA1C levels remained stable in the varoglutamstat group. Additionally, a reduction in plasma concentration of the inflammatory marker pE-CCL2 was noted (p=0.004), suggesting a strong anti-inflammatory effect. Varoglutamstat showed a good safety profile with no significant differences in adverse events between the treated diabetes subgroup and the overall study population.

Based on these promising results, Vivoryon Therapeutics has outlined a proposed Phase 2 clinical development plan for varoglutamstat in diabetic kidney disease (DKD). The planned study aims to include patients with more advanced DKD (stage 3b/4) and significant albuminuria/proteinuria. Approximately 120 subjects will be randomized to receive either varoglutamstat or placebo, in addition to standard of care medications. Key endpoints will include eGFR slope analysis, measures of albuminuria, and biomarkers related to inflammation and fibrosis, alongside safety assessments.

Vivoryon is collaborating with key medical and industry experts to refine its development strategy for varoglutamstat in inflammatory and fibrotic diseases. Among them are Dr. Tobias B. Huber, an expert in medicine and kidney function, and Florian Jehle, CEO of Vifor-FMC Renal Pharma, who will provide strategic business and commercial advice. Statistical analysis will be supported by Dr. Kevin Carroll, CEO of KJC Statistics.

Vivoryon Therapeutics N.V. continues to focus on developing small molecule-based medicines that modulate the activity and stability of proteins altered in disease settings. With a robust pipeline targeting Alzheimer's disease, inflammatory and fibrotic disorders, and cancer, Vivoryon aims to bring innovative treatments to patients with severe diseases.

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