Vivoryon Therapeutics N.V. Shares Highlights from Virtual Kidney Disease KOL Event
Vivoryon Therapeutics N.V. (VVY) hosted a virtual Kidney Disease Key Opinion Leader (KOL) Event on September 30, 2024, focusing on diabetic kidney disease (DKD) and the potential of their lead asset, varoglutamstat. Key takeaways include:
1. Chronic Kidney Disease (CKD) is a rising global health problem, with diabetes being a major risk factor.
2. Current treatments do not halt or reverse kidney function decline, highlighting a significant unmet need.
3. Varoglutamstat's novel mode of action targeting inflammatory and fibrotic pathways shows promise in addressing this need.
4. Analysis of the VIVIAD Phase 2b study data revealed a substantial treatment effect on eGFR slope, particularly in patients with type 2 diabetes.
5. The company plans to advance varoglutamstat into a Phase 2 study in DKD, currently in the planning stage.
Vivoryon Therapeutics N.V. (VVY) ha organizzato un evento virtuale con i Leader d'Opinione sulla Malattia Renale (KOL) il 30 settembre 2024, incentrato sulla malattia renale diabetica (DKD) e sul potenziale del loro asset principale, varoglutamstat. I punti chiave includono:
1. La Malattia Renale Cronica (CKD) rappresenta un crescente problema di salute globale, con il diabete come un importante fattore di rischio.
2. I trattamenti attuali non arrestano né invertiscono il declino della funzione renale, evidenziando un bisogno significativo non soddisfatto.
3. Il nuovo meccanismo d'azione di varoglutamstat, che mira alle vie infiammatorie e fibrotiche, mostra promesse per affrontare questo bisogno.
4. L'analisi dei dati dello studio VIVIAD Phase 2b ha rivelato un sostanziale effetto terapeutico sulla pendenza dell'eGFR, in particolare nei pazienti con diabete di tipo 2.
5. L'azienda prevede di portare varoglutamstat in uno studio di Fase 2 nella DKD, attualmente in fase di pianificazione.
Vivoryon Therapeutics N.V. (VVY) organizó un evento virtual de Líderes de Opinión Clave (KOL) sobre Enfermedades Renales el 30 de septiembre de 2024, centrándose en la enfermedad renal diabética (DKD) y el potencial de su activo principal, varoglutamstat. Los puntos clave incluyen:
1. La Enfermedad Renal Crónica (CKD) es un problema de salud global en aumento, siendo la diabetes un factor de riesgo importante.
2. Los tratamientos actuales no detienen ni revierten el deterioro de la función renal, subrayando una necesidad significativa no atendida.
3. El nuevo modo de acción de varoglutamstat, que apunta a las vías inflamatorias y fibrosas, muestra promesas en la atención de esta necesidad.
4. El análisis de los datos del estudio VIVIAD de Fase 2b reveló un efecto terapéutico sustancial en la pendiente del eGFR, especialmente en pacientes con diabetes tipo 2.
5. La compañía planea avanzar varoglutamstat a un estudio de Fase 2 en DKD, que actualmente está en etapa de planificación.
Vivoryon Therapeutics N.V. (VVY)는 2024년 9월 30일 가상 신장 질환 주요 의견 리더(KOL) 행사를 개최하였으며, 주로 당뇨병성 신장 질환 (DKD)과 그들의 주요 자산인 바로글루탐스타트의 잠재력에 초점을 맞추었습니다. 주요 내용은 다음과 같습니다:
1. 만성 신장 질환(CKD)은 증가하는 글로벌 건강 문제로, 당뇨병은 주요 위험 요소입니다.
2. 현재 치료 방법은 신장 기능 저하를 멈추거나 되돌리는 데 실패하고 있어, 충족되지 않은 중요한 필요성이 강조됩니다.
3. 염증 및 섬유증 경로를 목표로 하는 바로글루탐스타트의 새로운 작용 메커니즘은 이러한 필요를 해결하는 데 유망합니다.
4. VIVIAD 2b상 연구 데이터 분석 결과, 2형 당뇨병 환자에서 eGFR 기울기에 대한 상당한 치료 효과가 나타났습니다.
5. 회사는 DKD에 대한 Phase 2 연구로 바로글루탐스타트를 진전시킬 계획이며, 현재 계획 단계에 있습니다.
Vivoryon Therapeutics N.V. (VVY) a organisé un événement virtuel destiné aux Leaders d'Opinion Clés (KOL) sur les Maladies Rénales le 30 septembre 2024, en mettant l'accent sur la maladie rénale diabétique (DKD) et le potentiel de leur actif principal, varoglutamstat. Les principaux enseignements incluent :
1. La Maladie Rénale Chronique (CKD) constitue un problème de santé mondiale croissant, le diabète étant un facteur de risque majeur.
2. Les traitements actuels n'arrêtent ni ne renversent le déclin de la fonction rénale, soulignant un besoin non satisfait significatif.
3. Le mode d'action novateur de varoglutamstat, ciblant les voies inflammatoires et fibrotiques, montre une promesse dans la réponse à ce besoin.
4. L'analyse des données de l'étude VIVIAD Phase 2b a révélé un effet thérapeutique substantiel sur la pente de l'eGFR, en particulier chez les patients atteints de diabète de type 2.
5. La société prévoit d'avancer varoglutamstat dans une étude de Phase 2 sur la DKD, qui est actuellement en phase de planification.
Vivoryon Therapeutics N.V. (VVY) hat am 30. September 2024 eine virtuelle Veranstaltung mit Experten für Nierenerkrankungen (KOL) organisiert, die sich auf diabetische Nierenerkrankung (DKD) und das Potenzial ihres Hauptprodukts Varoglutamstat konzentrierte. Wichtige Erkenntnisse sind:
1. Chronische Nierenerkrankung (CKD) ist ein wachsendes globales Gesundheitsproblem, wobei Diabetes ein wesentlicher Risikofaktor ist.
2. Die aktuellen Behandlungen stoppen oder kehren den Rückgang der Nierenfunktion nicht um, was einen erheblichen ungedeckten Bedarf aufzeigt.
3. Der neuartige Wirkmechanismus von Varoglutamstat, der entzündliche und fibrotische Wege anspricht, zeigt vielversprechende Ansätze zur Bewältigung dieses Bedarfs.
4. Die Analyse der Daten der VIVIAD Phase 2b Studie ergab eine erheblichen Behandlungseffekt auf die eGFR-Neigung, insbesondere bei Patienten mit Typ-2-Diabetes.
5. Das Unternehmen plant, Varoglutamstat in eine Phase-2-Studie bei DKD voranzubringen, die sich derzeit in der Planungsphase befindet.
- Varoglutamstat showed a substantial treatment effect on eGFR slope compared to placebo in the VIVIAD study
- The company is planning to advance varoglutamstat into a Phase 2 study for diabetic kidney disease
- Varoglutamstat demonstrated a favorable safety and tolerability profile in previous clinical studies
- The drug's anti-inflammatory activity shows potential in addressing unmet needs in kidney disorders
- None.
Insights
The virtual KOL event on kidney disease highlights significant potential for Vivoryon's lead compound varoglutamstat in treating chronic kidney disease (CKD), particularly diabetic kidney disease (DKD). Key points include:
- CKD is a growing global health issue projected to become the 5th leading cause of years of life lost by 2040
- Current treatments don't halt or reverse kidney function decline
- Inflammation is a important driver of DKD progression
- Varoglutamstat showed promising efficacy in improving kidney function in the VIVIAD Phase 2b study, especially in diabetic patients
- There's significant market potential for varoglutamstat in stage 3b-4 CKD/DKD and rare kidney diseases
- Statistical analysis of the VIVIAD study data revealed substantial treatment effects on eGFR slope
These insights suggest varoglutamstat could address a major unmet need in kidney disease treatment if proven successful in future randomized clinical trials. The company's plans to advance into a Phase 2 study for DKD indicate a strategic expansion of varoglutamstat's potential applications beyond Alzheimer's disease.
This event highlights several key market dynamics for Vivoryon:
- Growing market: CKD is increasing globally, creating a large and expanding patient population
- High unmet need: Current treatments only delay progression, leaving significant room for new therapies
- Attractive market segment: Focus on stage 3b-4 CKD/DKD patients represents a high-value target group
- Pharma interest: Recent high-valuation deals demonstrate industry appetite for kidney disease treatments
- Potential for multiple indications: Beyond DKD, varoglutamstat shows promise in rare diseases like Alport and Fabry
The
Halle (Saale) / Munich, Germany, October 1, 2024 – 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 announced key takeaways from its virtual Kidney Disease Key Opinion Leader (KOL) Event held September 30, 2024. The event focused on the standard of care and existing medical need, market development and dynamics in kidney disorders, as well as on key statistical considerations in kidney disease drug development, with special emphasis on diabetic kidney disease (DKD).
The event, which was hosted by Frank Weber, MD, CEO of Vivoryon, featured presentations from Tobias B. Huber, MD, Chair of the Center of Internal Medicine and Director of the III. Department of Medicine, University Medical Center Hamburg-Eppendorf (UKE), Florian Jehle, renal pharmaceutical industry expert and Kevin Carroll, PhD, CEO, KJC Statistics.
“Our KOL event has shed light on the profound existing medical need of halting disease progression in kidney disease. It clearly outlined that, despite a number of treatments available and scientific advances made in this field over the past years, novel medicines are needed with mechanisms of action suitable to addressing the key inflammatory and fibrotic pathways underlying this disease,” said Frank Weber, MD, CEO of Vivoryon. “I would like to thank all speakers for participating and sharing their knowledge and unique perspectives shaped by their core expertise in key aspects of drug development in kidney disease. Building on the strong body of evidence of varoglutamstat’s ability to protect and improve kidney function, observed in particular in patients with diabetes, we now look forward to keeping the market updated on our progress in fully realizing the potential of Vivoryon’s lead asset varoglutamstat in kidney disease.”
Highlights from Dr. Huber’s presentation include:
- Chronic Kidney Disease (CKD) is a rising global health problem and is set to become the fifth leading cause of years of life lost by 2040.
- Treatments for CKD have advanced in recent years but still do not halt or reverse kidney function decline which will likely increase as the population ages.
- CKD manifests as a progressive decline in kidney function and can lead to significant disability and/or premature death and diabetes is a major risk factor for CKD.
- Inflammation is a key underlying pathway in driving progression of diabetic kidney disease (DKD) and other kidney disorders and targeting inflammatory pathways could represent an approach to address the unmet needs across both the broader CKD population as well as in the rare disease space.
- Observations from the VIVIAD Phase 2b study have shown that varoglutamstat, with its novel mode of action targeting inflammatory and fibrotic pathways and promising efficacy and safety profile to date, could become an interesting treatment option for patients, if proven successful in double blinded, randomized prospective clinical studies.
Highlights from Mr. Jehle’s presentation include:
- Late-stage CKD patients are at greatest risk of kidney failure requiring kidney replacement therapy (dialysis or transplant).
- End-stage renal disease and kidney failure is a major concern for not only patients and physicians, but also health care providers and payors, with costs escalating significantly with later stages of the disease.
- Rate of cardio-metabolic risk factors such as diabetes and hypertension as well as age are key dynamics in the CKD market.
- Current therapies such as SGLT2s and GLP1s only delay disease progression, but are no cure, consequently, a high unmet need remains for the majority of CKD and DKD patients.
- There is a significant market potential for oral varoglutamstat, in particular in the stage 4 and fast progressing stage 3b CKD and DKD patient populations, as well as certain rare diseases such as Alport syndrome and Fabry disease.
- Increasing interest from big pharma in kidney diseases has been demonstrated by recent deals with high valuations.
Highlights from Dr. Carroll’s presentation include:
- Analysis of the estimated glomerular filtration rate (eGFR) in CKD studies have evolved over the past 40 years and novel methods for statistical analysis are being applied, with the Random Coefficients (RC) Analysis emerging as preferred method.
- Measuring the eGFR slope via RC analysis was the primary efficacy endpoint in recent FDA approvals in CKD, as well as in many ongoing Phase 3 studies.
- Analysis of data from the VIVIAD study employing this method has yielded consistent findings for eGFR with varoglutamstat, with a substantial treatment effect on the eGFR slope seen for varoglutamstat compared to placebo in the overall population driven by an even larger effect in patients with type 2 diabetes.
- Available results from VIVIAD together with good statistical planning enables an efficient design of a Phase 2 study in patients with DKD stage 3/4 with an interim futility analysis after 62 patients treated for at least 24 weeks.
A replay of the webcast of the virtual R&D Event will be available via the Presentations & Webcasts page in the Investor Relations section on the Company's website at www.vivoryon.com.
###
Varoglutamstat in Kidney Disease
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 advancing development aiming to treat Alzheimer’s disease (AD), varoglutamstat has been investigated in a number of different clinical studies, all of which have consistently demonstrated a favorable safety and tolerability profile both in healthy volunteers and patients with AD. Based on the known anti-inflammatory activity of varoglutamstat, the protocol for the Phase 2 VIVIAD study in AD, which was completed in the first half of 2024, included the investigation of kidney function and measurement of biomarkers of kidney inflammation and fibrosis to explore the role of QPCT/L inhibition on kidney function. Although patients in VIVIAD were selected for their AD status and not for their kidney function level, many of them had reduced kidney function due to age and/or comorbidities. Analysis showed a statistically significant benefit of varoglutamstat on a prospectively defined key kidney function endpoint (eGFR) and a significant reduction of the pro-inflammatory cytokine pE-CCL2. A substantially higher treatment benefit of varoglutamstat on eGFR was observed in a post-hoc diabetes subgroup, triggering plans to advance varoglutamstat into Phase 2 study in DKD, which is currently in planning.
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 Contact
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Email: IR@vivoryon.com
Media Contact
Trophic Communications
Stephanie May
Tel: +49 171 1855682
Email: vivoryon@trophic.eu
Attachment
FAQ
What is the main focus of Vivoryon Therapeutics N.V.'s (VVY) recent KOL event?
What were the key findings from the VIVIAD Phase 2b study for Vivoryon's (VVY) varoglutamstat?
What are Vivoryon Therapeutics' (VVY) plans for varoglutamstat in kidney disease?
How does varoglutamstat potentially address the unmet needs in kidney disease treatment for Vivoryon (VVY)?
