Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
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Insights
Vivoryon's varoglutamstat shows significant kidney function improvement in Phase 2 trials, advancing toward diabetic kidney disease treatment.
The meta-analysis of Vivoryon's Phase 2 trials reveals statistically significant and clinically meaningful improvements in kidney function (measured by eGFR) for varoglutamstat, their lead drug candidate. What makes this particularly notable is the consistency of results across two independent studies (VIVIAD and VIVA-MIND), providing converging evidence that strengthens the reliability of these findings.
The improvements in kidney function began at week 24 and remained sustained through week 96, demonstrating durability of effect - a critical factor for chronic disease treatments. More importantly, the substantially larger effect size in diabetic patients has provided Vivoryon with a clear development pathway, now targeting diabetic kidney disease (DKD) for their upcoming Phase 2b trial.
This strategic pivot toward kidney disease represents a significant repositioning for Vivoryon, which was previously focused more broadly on inflammatory and fibrotic disorders. The company is now specifically targeting patients with diabetes and chronic kidney disease stage 3b/4, a substantial market with significant unmet medical needs.
The first-in-class mechanism of varoglutamstat as a glutaminyl cyclase inhibitor with dual anti-inflammatory and anti-fibrotic properties differentiates it from existing kidney disease treatments. This presentation at the ERA Congress elevates Vivoryon's visibility within the nephrology community at a critical juncture in the drug's development path.
Vivoryon Therapeutics N.V. Presents Meta-analysis Data of VIVIAD and VIVA-MIND studies at ERA 2025
Halle (Saale) / Munich, Germany, June 6, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that meta-analysis data for its lead drug in development, varoglutamstat, was presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, today, June 6, 2025.
“We are delighted that the results of the Phase 2 program were accepted for presentation at the ERA 2025 congress. This allowed Vivoryon to share the outstanding improvements of varoglutamstat on kidney function (eGFR) with the scientific and medical expert community in the kidney space,” said Frank Weber, MD, CEO of Vivoryon.
Presentation Highlights
Varoglutamstat is a first-in-class glutaminyl cyclase (QPCT/L) inhibitor with potent anti-inflammatory and anti-fibrotic effects. VIVIAD and VIVA-MIND, two independent Phase 2 studies in the EU and U.S. showed a statistically significant and clinically meaningful improvement in a prospectively defined kidney function parameter, eGFR, in an elderly patient population. This improvement was consistent in both trials independently, replicated in the meta-analysis and pooled analysis, and provides converging evidence for this finding. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes.
The next step is planned to be a dedicated Phase 2b trial in patients with diabetic kidney disease (patients with diabetes and chronic kidney disease stage 3b/4). The main goal will be to investigate the efficacy on eGFR in this patient population and to obtain additional information on a potential effect on proteinuria and other kidney specific markers.
Presentation Details
Date: June 6, 2025
Presentation time: 8:15 am CEST as part of the focused oral session
Title: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent Phase 2 studies
Venue: Vienna, Austria
Presenter: Frank Weber, MD, CEO of Vivoryon Therapeutics
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About Vivoryon Therapeutics N.V.
Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. www.vivoryon.com
Vivoryon Forward Looking Statements
This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law.
For more information, please contact:
Investor Contacts
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Email: IR@vivoryon.com
LifeSci Advisors
Sandya von der Weid
Tel: +41 78 680 05 38
Email: svonderweid@lifesciadvisors.com
Media Contact
Trophic Communications
Valeria Fisher or Verena Schossmann
Tel: +49 175 8041816 / +49 151 219 412 77
Email: vivoryon@trophic.eu
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