Vivoryon Therapeutics (VVY) Status Update summary

Unmet needs and disease landscape

• Kidney diseases affect over 10% of the population and are projected to become a leading cause of mortality by 2040, with both common and rare forms contributing significantly to end-stage renal disease.

• Current therapies slow but do not halt or reverse disease progression, highlighting a need for drugs that can stabilize or improve kidney function, especially in advanced and rare kidney diseases.

• Inflammatory pathways are central to disease progression, with fibrosis and loss of nephron function being common endpoints across etiologies.

Scientific and clinical rationale for Varoglutamstat

• Varoglutamstat, a glutaminyl cyclase inhibitor, has shown reduction in inflammation and fibrosis in preclinical models and promising increases in GFR in clinical data, particularly in diabetic subgroups.

• Decreases in pro-inflammatory markers such as CCL2 were observed in both animal and human studies, supporting the mechanism of action.

• Ongoing research collaborations aim to further characterize glutaminyl cyclase expression and its role in both common and rare kidney diseases.

Market and competitive landscape

• Chronic kidney disease (CKD) affects an estimated 800 million people globally, with late-stage patients facing high unmet need and significant healthcare costs, especially for dialysis and transplantation.

• Current pipeline activity is focused on rare diseases like IgAN and FSGS, but few candidates target advanced diabetic kidney disease or offer oral administration.

• Varoglutamstat's oral route and potential efficacy in stages 3B and 4 CKD position it as a strong candidate with limited competition and attractive market potential.