Vivoryon Therapeutics (VVY) R&D Update summary

Key clinical findings

• Varoglutamstat demonstrated a statistically significant improvement in kidney function (eGFR) in the VIVIAD phase IIb study, with a 3.4 mL/min per year benefit over placebo, and an even greater effect of 8.2 mL/min per year in the diabetes subgroup, both highly significant.

• The effect was robust across methodologies, including creatinine and cystatin C-based eGFR calculations, and consistent across subgroups such as those with hypertension and cardiac disorders, and was sustained for up to two years.

• Additional benefits in the diabetes subgroup included mild weight loss (average -3.8 kg), reduced diastolic blood pressure (-5.8 mmHg), and improved liver enzyme levels.

• Varoglutamstat was well tolerated, with adverse event rates comparable to placebo and no new safety signals or increased proteinuria in either the overall or diabetes populations.

• The drug’s mechanism appears to be anti-inflammatory, with a significant reduction in pyroglutamyl-CCL2, a potent inflammatory cytokine.

Clinical development strategy

• Plans are in place for a new phase II study in patients with advanced (stage 3b/4) diabetic kidney disease (DKD), to be conducted on top of standard of care, pending additional funding or partnerships.

• The proposed study will enroll up to 120 patients for 15 months, aiming for an 80% power to detect a 5 mL/min eGFR difference, with endpoints including eGFR slope, albumin-creatinine ratio, and biomarkers of inflammation and fibrosis.

• Parallel non-clinical and mechanistic studies are planned to prioritize further indications, including orphan kidney disorders such as Alport and Fabry diseases.

• Collaborations have been established with leading nephrology experts, statisticians, and industry advisors to support clinical and strategic development.

Market and competitive landscape

• DKD represents a large unmet need, with 40% of diabetes patients at risk and current therapies (e.g., SGLT2 inhibitors, semaglutide) offering only modest improvements in eGFR (1–1.6 mL/min per year).

• Varoglutamstat’s effect size in the diabetes subgroup is substantially greater than existing therapies, and the placebo group’s progression mirrored that seen in major comparator studies.

• The company is shifting strategic focus to kidney disease, aiming to position varoglutamstat as the first oral treatment to improve kidney function on top of standard care.