Vivoryon Therapeutics' new DKD drug 'Baragrutamstat' demonstrates confirmed efficacy in Phase II clinical trials... Significant improvement observed in elderly patients

Vivoryon Therapeutics announced further data demonstrating the potential of glutaminyl cyclase as a therapeutic target for diabetic nephropathy, thereby enhancing the development prospects of varoglutamstat. The signals of renal function improvement observed in the Phase 2 clinical study were more pronounced in the elderly diabetic patient population, drawing attention to its potential as a next-generation therapeutic strategy.

Vivoryon Therapeutics announced that additional analysis results from the varoglutamstat Phase 2 clinical program would be presented at the World Congress of Nephrology (WCN) held in Yokohama, Japan, starting March 28. This release took place at this representative academic conference organized by the International Society of Nephrology, which saw widespread participation from global kidney disease experts.

The core finding is that the “glutaminyl cyclase” inhibition mechanism can directly target the inflammation and fibrosis pathways of diabetic nephropathy. The company explained that a pooled analysis of the independently conducted VIVIAD and VIVA-MIND Phase 2 clinical data confirmed a consistent and meaningful improvement effect of varoglutamstat on renal function in diabetic patients.

Notably, regarding the changes in estimated glomerular filtration rate (eGFR), the improvement in the elderly diabetic patient population was greater compared to the non-diabetic group, and patients with a baseline eGFR average at a lower level (approximately 60 mL/min/1.73m²) also showed effects similar to or better than the overall diabetic patient population. This suggests that therapeutic benefits may be expected even in patients with disease progression.

Significant results were also observed in animal models. In analyses of the DKD mouse model, overall positive changes in key indicators such as reduced inflammation, improved glomerulosclerosis, and restored renal function were noted. These results support the notion that ‘varoglutamstat’ has the potential to become a treatment option that not only alleviates symptoms but also intervenes in the fundamental pathological processes of the disease.

Vivoryon CEO Frank Weber stated, “These data provide further evidence that glutaminyl cyclase inhibition can directly address molecular changes in diabetic nephropathy,” adding, “This will help to change the treatment paradigm for kidney diseases globally.”

Industry experts generally regard these results as a “significant turning point.” Existing DKD treatments focus on blood sugar and blood pressure management, while the development of targeted therapies addressing the core mechanisms of inflammation and fibrosis is still in its early stages. A nephrology expert commented, “Maintaining efficacy in elderly patients and those with moderate to severe stages is an important indicator for assessing its commercialization potential.”

Vivoryon Therapeutics plans to expand the development of varoglutamstat in the future, targeting diabetic patients as well as patients in later stages of chronic kidney disease (CKD). The evidence accumulated from this release not only strengthens the feasibility of glutaminyl cyclase as a “target for DKD treatment” but also increases the likelihood of establishing a new competitive landscape in the global kidney disease treatment market.