Vivoryon Therapeutics N.V. Provides R&D-Update Further Strengthening Development Pipeline in Kidney Disease
Vivoryon Therapeutics has announced significant developments in its kidney disease pipeline. A meta-analysis of VIVIAD and VIVA-MIND studies revealed that varoglutamstat treatment at 600mg twice daily significantly improved kidney function (eGFR) in the overall study population of 286 patients. The improvement became significant after 24 weeks and was maintained for up to 2 years.
The analysis showed a notably larger effect in patients with diabetes compared to those without. Of the total participants, 39 had diabetes (19 on varoglutamstat, 20 on placebo) while 247 were non-diabetic. The company has strengthened its patent portfolio with three new filings, including a composition of matter patent for varoglutamstat's active polymorph.
Vivoryon's key 2025 priority is advancing varoglutamstat in kidney disease through a planned Phase 2b study in diabetic kidney disease (DKD). Additionally, they've nominated a novel QPCT/L inhibitor candidate, VY2149, for development in inflammatory and fibrotic diseases.
Vivoryon Therapeutics ha annunciato sviluppi significativi nel suo pipeline per le malattie renali. Un'analisi meta degli studi VIVIAD e VIVA-MIND ha rivelato che il trattamento con varoglutamstat a 600mg due volte al giorno ha migliorato significativamente la funzione renale (eGFR) nella popolazione complessiva di studio di 286 pazienti. Il miglioramento è diventato significativo dopo 24 settimane ed è stato mantenuto fino a 2 anni.
L'analisi ha mostrato un effetto notevolmente maggiore nei pazienti diabetici rispetto a quelli non diabetici. Tra i partecipanti totali, 39 avevano diabete (19 in trattamento con varoglutamstat, 20 in placebo), mentre 247 erano non diabetici. L'azienda ha rafforzato il proprio portafoglio brevetti con tre nuove domande, inclusa una domanda di brevetto per la composizione di materia relativa al polimorfo attivo di varoglutamstat.
La priorità principale di Vivoryon per il 2025 è avanzare con varoglutamstat nelle malattie renali attraverso uno studio di Fase 2b pianificato per la malattia renale diabetica (DKD). Inoltre, hanno nominato un nuovo candidato inibitore QPCT/L, VY2149, per lo sviluppo in malattie infiammatorie e fibrotiche.
Vivoryon Therapeutics ha anunciado desarrollos significativos en su pipeline para enfermedades renales. Un meta-análisis de los estudios VIVIAD y VIVA-MIND reveló que el tratamiento con varoglutamstat a 600mg dos veces al día mejoró significativamente la función renal (eGFR) en la población de estudio general de 286 pacientes. La mejora se volvió significativa después de 24 semanas y se mantuvo durante hasta 2 años.
El análisis mostró un efecto notablemente mayor en pacientes con diabetes en comparación con aquellos sin diabetes. De los participantes totales, 39 tenían diabetes (19 en tratamiento con varoglutamstat, 20 en placebo) mientras que 247 eran no diabéticos. La compañía ha fortalecido su cartera de patentes con tres nuevas solicitudes, incluida una patente de composición de materia para el polimorfo activo de varoglutamstat.
La prioridad clave de Vivoryon para 2025 es avanzar con varoglutamstat en enfermedades renales a través de un estudio de Fase 2b planeado en enfermedad renal diabética (DKD). Además, han nominado un nuevo candidato a inibidor QPCT/L, VY2149, para su desarrollo en enfermedades inflamatorias y fibróticas.
Vivoryon Therapeutics는 신장 질환 파이프라인에서 중요한 발전을 발표했습니다. VIVIAD 및 VIVA-MIND 연구의 메타 분석에 따르면, varoglutamstat를 하루 두 번 600mg 투여한 결과 286명의 전체 연구 집단에서 신장 기능(eGFR)이 유의미하게 개선되었습니다. 24주 후에 개선이 유의미해졌으며, 최대 2년까지 유지되었습니다.
분석 결과, 당뇨병 환자의 경우 비당뇨병 환자보다 효과가 더 크게 나타났습니다. 전체 참가자 중 39명이 당뇨병을 앓고 있었으며(19명이 varoglutamstat, 20명이 위약), 247명은 비당뇨병 환자였습니다. 회사는 varoglutamstat의 활성 고형체에 대한 물질 조성 특허를 포함하여 새로운 세 개의 특허 출원을 통해 특허 포트폴리오를 강화했습니다.
Vivoryon의 2025년 주요 목표는 당뇨병성 신장 질환(DKD)을 대상으로 하는 계획된 2b상 연구를 통해 varoglutamstat를 신장 질환에서 발전시키는 것입니다. 또한, 염증 및 섬유화 질환의 발전을 위해 새로운 QPCT/L 억제제 후보인 VY2149를 지명했습니다.
Vivoryon Therapeutics a annoncé des développements significatifs dans son pipeline sur les maladies rénales. Une méta-analyse des études VIVIAD et VIVA-MIND a révélé que le traitement avec varoglutamstat à 600mg deux fois par jour a considérablement amélioré la fonction rénale (eGFR) dans la population globale de l'étude de 286 patients. L'amélioration est devenue significative après 24 semaines et a été maintenue pendant jusqu'à 2 ans.
L'analyse a montré un effet de manière notable plus important chez les patients diabétiques par rapport à ceux n'ayant pas de diabète. Parmi les participants totaux, 39 avaient le diabète (19 sous varoglutamstat, 20 sous placebo), tandis que 247 étaient non diabétiques. L'entreprise a renforcé son portefeuille de brevets avec trois nouvelles demandes, y compris un brevet de composition de matière pour le polymorphe actif de varoglutamstat.
La priorité clé de Vivoryon pour 2025 est de faire progresser varoglutamstat dans les maladies rénales à travers une étude de Phase 2b prévue dans la maladie rénale diabétique (DKD). De plus, ils ont désigné un nouveau candidat inhibiteur de QPCT/L, VY2149, pour le développement dans des maladies inflammatoires et fibreuses.
Vivoryon Therapeutics hat bedeutende Entwicklungen in seiner Pipeline für Nierenerkrankungen bekannt gegeben. Eine Metaanalyse der Studien VIVIAD und VIVA-MIND ergab, dass die Behandlung mit varoglutamstat bei 600mg zweimal täglich die Nierenfunktion (eGFR) in der gesamten Studienpopulation von 286 Patienten signifikant verbesserte. Die Verbesserung wurde nach 24 Wochen signifikant und hielt bis zu 2 Jahre an.
Die Analyse zeigte einen bemerkenswert größeren Effekt bei Patienten mit Diabetes im Vergleich zu jenen ohne. Von den insgesamt 39 Teilnehmern hatten 19 Diabetes (19 mit varoglutamstat, 20 mit Placebo), während 247 nicht-diabetisch waren. Das Unternehmen hat sein Patentportfolio mit drei neuen Anmeldungen, einschließlich eines Patents für die Materiezusammensetzung des aktiven Polymorphs von varoglutamstat, gestärkt.
Vivoryons Priorität für 2025 ist die Weiterentwicklung von varoglutamstat bei Nierenerkrankungen durch eine geplante Phase-2b-Studie bei diabetischer Nierenerkrankung (DKD). Zusätzlich wurde ein neuer Kandidat für einen QPCT/L-Inhibitor, VY2149, für die Entwicklung bei entzündlichen und fibrotischen Erkrankungen nominiert.
- Significant improvement in kidney function (eGFR) demonstrated in clinical trials
- Larger treatment effect observed in diabetic patients
- Three new patent filings strengthening intellectual property protection until 2044
- Nomination of new drug candidate VY2149 for inflammatory and fibrotic diseases
- Future studies dependent on additional funding and/or partnership
- Primary and secondary endpoints in early Alzheimer's disease were not met in VIVIAD and VIVA-MIND studies
Insights
The meta-analysis of VIVIAD and VIVA-MIND trials reveals compelling kidney function data for varoglutamstat. The significant improvement in eGFR starting at 24 weeks and maintaining efficacy up to 2 years demonstrates sustained therapeutic benefit. Most notably, the enhanced effect in diabetic patients suggests a particularly strong therapeutic potential in the diabetic kidney disease (DKD) population.
The planned Phase 2b study in advanced DKD patients is strategically sound, targeting a high-unmet need population with stage 3b/4 disease. The inclusion of biomarkers for inflammation and fibrosis will provide important mechanistic insights. The nomination of VY2149 as a next-generation QPCT/L inhibitor strengthens the company's pipeline redundancy.
The expansion of Vivoryon's patent portfolio is strategically significant. The new composition of matter patent on varoglutamstat's active polymorph, if granted, would provide market exclusivity until 2044. This substantially extends the commercial runway. The additional medical use and dosing patents create a robust IP fortress. The prioritized examination timeline of 12 months for the composition patent is favorable for maintaining competitive advantages.
From a market perspective, this R&D update strengthens Vivoryon's position in the lucrative kidney disease space. The diabetic kidney disease market represents a substantial opportunity, with high unmet need. The dual approach of pursuing both DKD and rare kidney diseases provides multiple shots on goal. The development of VY2149 for inflammatory and fibrotic diseases expands the addressable market. However, the dependency on additional funding or partnerships for future studies introduces execution risk that investors should monitor.
Vivoryon Therapeutics N.V. Provides R&D-Update Further Strengthening Development Pipeline in Kidney Disease
- A meta-analysis of VIVIAD and VIVA-MIND1 data confirmed that treatment with varoglutamstat at 600mg twice daily significantly improved eGFR2 kidney function in the overall study population
- The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes3 compared to those without diabetes
- Vivoryon further strengthened its patent portfolio for varoglutamstat in kidney disease, including patent filings on medical use, dosing and a new composition of matter patent on the active polymorph
- A novel, next-generation QPCT/L inhibitor candidate with compelling pharmacological activity was nominated for development in inflammatory and fibrotic diseases, including potentially in DKD/CKD and orphan diseases
Halle (Saale) / Munich, Germany, January 14, 2025 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today provided an update on the Company’s progress of varoglutamstat development in kidney disease and efforts to solidify its QPCT/L inhibitor pipeline in inflammatory and fibrotic diseases.
“Vivoryon has thoroughly analyzed kidney function data of the two independent Phase 2 studies VIVIAD and VIVA-MIND. The results were highly consistent between the two studies which were carried out in different regions (EU vs U.S.) and with different CROs and laboratories. In both studies, a significant improvement in kidney function measured by eGFR was demonstrated in the overall population and, also in both studies, patients with diabetes displayed a substantially larger effect size than patients without diabetes. These findings were confirmed by a recently completed meta-analysis,” said Frank Weber, MD, CEO of Vivoryon. “We also enhanced the value of our development pipeline by adding three new patent filings to our patent portfolio, including a composition of matter patent of the active polymorph for varoglutamstat, as well as by identifying and nominating a novel and potent QPCT/L inhibitor for development in inflammatory and fibrotic diseases. Vivoryon is developing a highly innovative, focused portfolio of QPTC/L inhibitors grounded in the proof that QPCT/L inhibition leads to reduction in the activity of potent pro-inflammatory and fibrotic peptides.”
VIVIAD and VIVA-MIND: Meta-analysis All Patients
- A total of 286 patients were randomized into the 600mg twice daily (BID) varoglutamstat and placebo groups in VIVIAD and VIVA-MIND studies, with 112 allocated to 600mg BID varoglutamstat and 174 to placebo.
- Meta-analysis of VIVIAD and VIVA-MIND data confirmed that treatment with varoglutamstat at 600mg BID significantly improved kidney function as measured by eGFR (estimated glomerular filtration rate) in the overall population.
- The difference of change from baseline in eGFR between varoglutamstat and placebo became significant starting after 24 weeks of treatment and the treatment effect was maintained throughout the study duration up to 2 years (96 weeks).
See Figure 1
VIVIAD and VIVA-MIND Meta-analysis: Stratification in Patients with Diabetes and without Diabetes
- A total of 39 patients with diabetes were randomized into the 600mg BID varoglutamstat (n=19) and placebo (n=20) groups in total (VIVIAD n=23, VIVA-MIND n=16).
- The corresponding numbers for study participants without diabetes were 93 patients randomized to varoglutamstat 600mg BID and 154 patients randomized to placebo (total n=247).
- The effect size is substantially larger in patients with diabetes compared to patients without diabetes, starting 24 weeks after initiation of treatment and sustained until the end of treatment.
- The results were consistent between VIVIAD and VIVA-MIND.
- A positive and statistically significant treatment effect was also observed in patients without diabetes.
See Figure 2
Key Strategic Priority for 2025: Focus on Planned Study in Diabetic Kidney Disease (DKD)
Vivoryon’s key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD). The proposed study is expected to include up to 120 subjects with stage 3b/4 DKD, randomized 1:1 to varoglutamstat 600mg orally twice daily or placebo, on top of standard of care medications. Intended endpoints include eGFR slope analysis, measures of albuminuria (UA(p)CR), inflammation and fibrosis-related biomarkers, as well as safety. Exploring the potential of varoglutamstat in rare kidney diseases, depending on additional non-clinical data, the Company intends to initiate a small proof of concept study of varoglutamstat in orphan kidney disorders. Initiation of all future studies is subject to additional funding and/or partnership, which Vivoryon will continue to actively explore.
Strengthened Varoglutamstat Patent Portfolio in Kidney Disease
Vivoryon has a strong patent portfolio for QPTC/L inhibition. As of December 31, 2024, Vivoryon’s patent portfolio consisted of 20 owned patent families, which comprise approximately 402 national patent applications and issued patents. In 2024, the Company further strengthened the patent portfolio with regard to its frontrunner molecule varoglutamstat (PQ912) and applications in kidney diseases. These activities included patent filings on (1) medical use in kidney diseases, (2) dosing and (3) a new composition of matter patent on the active polymorph form for PQ912, which, if granted, would extend the natural patent runtime for PQ912 to 2044. This patent was filed in mid-2023 and prioritized examination for this composition of matter patent has been initiated. The examination process and potential granting should be expected within 12 months.
Novel Candidate for Development in Inflammatory and Fibrotic Diseases
The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is expected to enter formal, late-stage preclinical development within this year, subject to additional funding and/or partnership, which Vivoryon will continue to actively explore.
Upcoming Investor Meetings
The Company will be hosting investor meetings January 14/15, 2025 around the J. P. Morgan conference in San Francisco, at which these updates will be shared. You can find a copy of the presentation that will be used in the investor meetings, including updated data from the VIVIAD/VIVA-MIND meta-analysis in the Investor section on the Company’s website at https://www.vivoryon.com/news-and-events/presentations-webcasts/.
Definitions and notes:
1 VIVIAD and VIVA-MIND Phase 2 studies in early Alzheimer's disease (AD) included prospectively defined measures of kidney function as safety and other exploratory endpoints, the primary and secondary endpoints in early AD were not met
2 eGFR: estimated glomerular filtration rate, a validated measure of kidney function
3 Defined as patients having at baseline either medical history of diabetes (type 1 or 2) and/or comedication with drugs used in diabetes and/or untreated with an HbA1c >
Figures: MDRD method: modification of diet in renal disease method
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About Varoglutamstat
Varoglutamstat (PQ912) is a proprietary, potent and selective inhibitor of human glutaminyl cyclases QPCT and QPCTL with therapeutic potential in indications including inflammatory and fibrotic diseases, neurodegenerative diseases, cancer and others. Initially advanced development aiming to treat Alzheimer’s disease (AD), varoglutamstat has been investigated in a number of different clinical studies. Based on the known anti-inflammatory and anti-fibrotic activity of varoglutamstat, the protocol for the Phase 2b VIVIAD study in early AD included the investigation of kidney function (measured using eGFR) and measurement of biomarkers of kidney inflammation and fibrosis to explore the role of QPCT/L inhibition on kidney function. eGFR was also analyzed as a prospectively defined safety parameter in the VIVA-MIND Phase 2 study in the U.S.
About Vivoryon Therapeutics N.V.
Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by its passion for ground-breaking science and innovation, the Company strives to change the lives of patients in need suffering from severe diseases. The Company leverages its in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. The Company has established a pipeline of orally available small molecule inhibitors for various indications including Alzheimer’s disease, inflammatory and fibrotic disorders, including of the kidney, and cancer. 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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