Vivoryon Therapeutics N.V. Presents Phase 2 Kidney Function and Biomarker Data at the American Society of Nephrology Kidney Week 2025
Vivoryon Therapeutics (Euronext: VVY) presented Phase 2 kidney function and biomarker data on November 6, 2025 at ASN Kidney Week 2025. A late-breaking poster titled “Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial” reported that a decrease in pE-CCL2 at week 48 correlated significantly with a positive (improved) eGFR slope on an individual-patient level. Prior VIVIAD Phase 2b results also linked pE-CCL2 reduction with eGFR improvement across dose groups and in participants with and without diabetes. Vivoryon said it plans a dedicated Phase 2b in advanced diabetic kidney disease (DKD stage 3b/4), with initiation subject to additional funding or partnership.
Vivoryon Therapeutics (Euronext: VVY) ha presentado datos de la fase 2 sobre la función renal y biomarcadores el 6 de noviembre de 2025 durante la ASN Kidney Week 2025. Un cartel de última hora titulado “Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial” informó que una disminución de pE-CCL2 en la semana 48 se correlacionó de manera significativa con una pendiente de eGFR positiva (mejora) a nivel individual del paciente. Resultados previos de VIVIAD en fase 2b también vincularon la reducción de pE-CCL2 con la mejora de eGFR entre grupos de dosis y en participantes con y sin diabetes. Vivoryon dijo que planea un estudio dedicado de fase 2b en la enfermedad renal diabética avanzada (DKD estadio 3b/4), con el inicio sujeto a financiamiento adicional o a una asociación.
Vivoryon Therapeutics (Euronext: VVY) presentó datos de la fase 2 sobre la función renal y biomarcadores el 6 de noviembre de 2025 durante ASN Kidney Week 2025. Un póster de última hora titulado “Correlación entre eGFR y pE-CCL2 en pacientes adultos mayores tratados con Varoglutamstat: datos de VIVIAD, un ensayo clínico aleatorizado de fase 2B” informó que una disminución de pE-CCL2 en la semana 48 se correlacionó de manera significativa con una pendiente de eGFR positiva (mejora) a nivel individual del paciente. Resultados previos de VIVIAD fase 2b también vincularon la reducción de pE-CCL2 con la mejora de eGFR a través de grupos de dosis y en participantes con y sin diabetes. Vivoryon dijo que planea una fase 2b dedicada en la enfermedad renal diabética avanzada (DKD estadio 3b/4), con inicio sujeto a financiamiento adicional o asociación.
Vivoryon Therapeutics (Euronext: VVY)는 2025년 11월 6일 ASN Kidney Week 2025에서 2상 신장 기능 및 바이오마커 데이터를 발표했습니다. Varoglutamstat로 치료받은 노인 환자들에서의 eGFR와 pE-CCL2의 상관관계: VIVIAD의 데이터, 2상B 무작위 임상시험라는 제목의 최신 포스터는 주 48에 pE-CCL2의 감소가 개인 환자 수준에서 양의(개선된) eGFR 기울과 유의미하게 상관관계가 있음을 보고했습니다. 이전의 VIVIAD 2b 결과 역시 용량군 간 및 당뇨병 여부에 관계없이 pE-CCL2 감소와 eGFR 개선을 연결했습니다. Vivoryon은 고도 당뇨병성 신장 질환(DKD 3b/4 단계)에서의 전용 2b 연구를 계획하고 있으며, 시작은 추가 자금 조달 또는 파트너십에 달려 있다고 밝혔습니다.
Vivoryon Therapeutics (Euronext: VVY) a présenté des données de phase 2 sur la fonction rénale et les biomarqueurs le 6 novembre 2025 lors de l'ASN Kidney Week 2025. Un poster de dernière minute intitulé « Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial » a rapporté qu’une diminution de pE-CCL2 à la semaine 48 corrélait de manière significative avec une pente d’eGFR positive (améliorée) au niveau individuel du patient. Les résultats antérieurs de VIVIAD en phase 2b ont également lié la réduction de pE-CCL2 à l’amélioration de l’eGFR à travers les groupes de doses et chez les participants avec ou sans diabète. Vivoryon a déclaré qu’il prévoit une phase 2b dédiée chez les patients atteints d’une maladie rénale diabétique avancée (DKD stade 3b/4), avec un démarrage soumis à un financement supplémentaire ou à un partenariat.
Vivoryon Therapeutics (Euronext: VVY) präsentierte am 6. November 2025 während der ASN Kidney Week 2025 Daten der Phase-2-Funktion der Nieren und Biomarker. Ein am späten Abend veröffentlichter Poster mit dem Titel „Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial“ berichtete, dass eine Verringerung von pE-CCL2 in Woche 48 signifikant mit einer positiven (verbesserten) eGFR-Steigung auf individueller Patientensebene korreliert. Frühere VIVIAD-Phase-2b-Ergebnisse verbindenen ebenfalls die Reduktion von pE-CCL2 mit einer Verbesserung der eGFR über Dosisgruppen hinweg und bei Teilnehmern mit und ohne Diabetes. Vivoryon erklärte, dass es eine dedizierte Phase-2b-Studie bei fortgeschrittener diabetischer Nierenerkrankung (DKD Stadium 3b/4) plant, deren Start von zusätzlicher Finanzierung oder Partnerschaft abhängt.
Vivoryon Therapeutics (Euronext: VVY) قدمت بيانات المرحلة 2 الخاصة بوظيفة الكلى والبارومترات الحيوية في 6 نوفمبر 2025 خلال أسبوع ASN Kidney Week 2025. أظهر poster مناقشة حديثة بعنوان “Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial” أن انخفاض pE-CCL2 في الأسبوع 48 ارتبط بشكل كبير بميل eGFR إيجابي (محسن) على مستوى المريض الفردي. كما ربطت نتائج VIVIAD في المرحلة 2b السابقة انخفاض pE-CCL2 بتحسن eGFR عبر مجموعات الجرعات وفي المشاركين المصابين بالسكري وبغير المصابين به. قالت Vivoryon إنها تخطط لإجراء دراسة Phase 2b مخصصة في مرض الكلية السكري المتقدم (DKD المرحلة 3b/4)، على أن يكون البدء مشروطاً بتمويل إضافي أو شراكة.
- Statistically significant correlation between pE-CCL2 change (week 48) and eGFR slope
- Phase 2b VIVIAD data showed pE-CCL2 reduction linked to eGFR improvement across dose groups
- Observed eGFR stabilization and improvement signals in study participants
- Planned dedicated Phase 2b study targeting DKD stage 3b/4
- Planned Phase 2b initiation is contingent on additional funding or partnership
- Current evidence is from Phase 2 analyses and requires confirmatory trials
Insights
Phase 2b data show a significant correlation between reduced pE-CCL2 and improved eGFR slope, supporting varoglutamstat's renal activity.
Vivoryon presented VIVIAD Phase 2b analyses on
The business mechanism is straightforward: biomarker reduction aligns with functional kidney benefit, which supports the proposed mode of action for varoglutamstat. Key dependencies and risks include the need for confirmatory randomized data in a dedicated population and the company’s stated funding/partnership condition for initiating the planned Phase 2b trial in advanced DKD stage 3b/4, which directly affects timelines and program de-risking.
Watch for a formal protocol and initiation milestones for the targeted Phase 2b in advanced diabetic kidney disease and any announced financings or partnerships; those items will determine whether and when confirmatory testing begins over the next 6–18 months.
Vivoryon Therapeutics N.V. Presents Phase 2 Kidney Function and Biomarker Data at the American Society of Nephrology Kidney Week 2025
- Compelling kidney function data from VIVIAD Phase 2b study presented in late-breaking poster at ASN kidney week, the world’s premier nephrology meeting
- VIVIAD analyses continue to support varoglutamstat’s potential in kidney disease, and consistently provide further evidence for a beneficial impact on kidney function based on its proposed mechanism of action
Halle (Saale) / Munich, Germany, November 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 the presentation of clinical study data from the Company’s lead investigational medicine in development, varoglutamstat, in a late-breaking poster today, November 6, 2025, at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas.
The poster titled “Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial” featured Phase 2 clinical study data underscoring varoglutamstat’s unique ability to stabilize and even improve kidney function, as measured by eGFR values.
Results from Vivoryon’s VIVIAD Phase 2b study previously showed that reduction of the anti-inflammatory biomarker pE-CCL2 was associated with an improvement of kidney function as measured by eGFR in study participants with and without diabetes at a dose group level. In line with these results, the poster highlights further analyses of total population data from the VIVIAD study evaluating the correlation of pE-CCL2 levels and eGFR slope on an individual participant level, which revealed a statistically significant correlation between the change from baseline in pE-CCL2 serum levels at week 48 and the eGFR slope over time. Specifically, a decrease in pE-CCL2 was significantly correlated with a positive (improved) eGFR slope.
“We are truly grateful for the opportunity to share our consistently compelling results with world leading scientific and medical experts in the kidney field at ASN Kidney week, considered to be the world’s premier nephrology congress,” said Frank Weber, MD, CEO of Vivoryon. “Inflammation is known to be a key driver in diabetic kidney disease and our data to date show clearly that inhibition of glutaminyl-cyclases with varoglutamstat is a promising new approach to treat diabetic kidney disease and other chronic diseases of the kidney. Every step forward strengthens our belief that, with varoglutamstat, we have a unique opportunity to develop a game-changing medicine with the potential to go beyond current standard of care and meaningfully improve kidney function in people with kidney disease.”
Vivoryon is planning to confirm the previously reported compelling data from its two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a dedicated Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.
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About VIVIAD / Methods
VIVIAD (NCT04498650) is a randomized clinical trial (Phase 2b) in 259 patients with early Alzheimer’s disease treated with 300 or 600 mg varoglutamstat, or placebo, BID for 48-96 weeks. Measurement of eGFR and biomarkers of inflammation were prospectively defined. pE-CCL2 serum levels were measured at baseline and at week 48 with an ELISA. Individual patient slopes of eGFR (MDRD formula) were calculated using random-coefficient analysis. Spearman correlations were calculated with R.
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 Contact
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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