Vivoryon Therapeutics Reports Exceptional Phase 2b Varoglutamstat Results on Kidney Function at ASN Kidney Week 2024

Vivoryon Therapeutics N.V. has presented impressive Phase 2b results for its investigational drug, varoglutamstat, during the American Society of Nephrology (ASN) Kidney Week 2024. This event in San Diego, California, is recognized as the leading nephrology conference globally. The presentation, led by CEO Frank Weber, M.D., showcased varoglutamstat’s potential to significantly enhance kidney function, particularly in elderly patients without proteinuria, offering a novel approach for treating diabetic kidney disease (DKD).

Varoglutamstat is a selective inhibitor of glutaminyl cyclases, which plays a crucial role in reducing inflammation and fibrosis by diminishing certain chemokines and pro-fibrotic peptides. This mechanism positively impacts kidney function, making it a promising candidate for further development in kidney disease treatments.

The Phase 2b clinical study, named VIVIAD, was a multicenter, randomized, double-blind, placebo-controlled, parallel group dose-finding study involving 259 participants with Alzheimer’s disease. The average age of participants was over 68 years, and they were administered either 300mg or 600mg doses of varoglutamstat or a placebo twice daily over a period of 48-96 weeks. Key kidney-related assessments included measurements of estimated glomerular filtration rate (eGFR), urine dipstick tests, and vital signs every 12 weeks. The diabetes subgroup comprised approximately 12% of the participants.

The results revealed that varoglutamstat significantly improved eGFR compared to placebo in both the overall study population and the diabetes subgroup. The diabetes subgroup showed an impressive treatment effect, with an 8.2mL/min/1.73m2/year improvement (p=0.02), compared to a 3.4mL/min/1.73m2/year improvement (p<0.001) in the overall population. These findings were consistent across various validated methods for eGFR assessment, including the 2021 CKD-EPI cystatin C and creatinine-cystatin C formulas.

Furthermore, the study demonstrated varoglutamstat’s excellent safety and tolerability profile. There were no signs of increased proteinuria, and the majority of participants exhibited no proteinuria throughout the study. Robust safety data confirmed that varoglutamstat did not cause adverse kidney effects over the two-year study duration, with no significant differences in renal and metabolic adverse events between the treatment and placebo groups.

Encouraged by these positive outcomes, Vivoryon is planning a new Phase 2 study to further evaluate varoglutamstat in patients with stage 3b/4 DKD. This upcoming study will be placebo-controlled and will investigate additional endpoints, including albuminuria/proteinuria and biomarkers related to inflammation and fibrosis. Additionally, Vivoryon is exploring the potential of varoglutamstat in treating rare kidney disorders such as Fabry disease and Alport syndrome.

Frank Weber, M.D., expressed pride in presenting these findings to the nephrology community and highlighted the significant potential of varoglutamstat in improving kidney function. He emphasized the unique profile of varoglutamstat as an oral treatment for kidney disorders and its potential to address a wide range of kidney diseases beyond DKD.

In conclusion, Vivoryon Therapeutics N.V. has made significant progress with its investigational drug varoglutamstat, demonstrating its potential to improve kidney function in elderly patients and those with diabetes. The compelling efficacy and safety data presented at ASN Kidney Week 2024 pave the way for further clinical development and the potential to provide a much-needed novel treatment option for patients suffering from kidney diseases.