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Home  /   Forum   /   Vivoryon Therapeutics   /   Vivoryon in 2024: Overname, Deal of Down the Drain?

Aandeel VIVORYON THERAPEUTICS N.V. AEX:VVY.NL, NL00150002Q7

Laatste koers (eur) Verschil Volume
1,960   +0,020   (+1,03%) Dagrange 1,922 - 1,988 90.602   Gem. (3M) 225,9K

Vivoryon in 2024: Overname, Deal of Down the Drain?

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2.798 Posts
Pagina: «« 1 ... 118 119 120 121 122 ... 140 »» | Laatste | Omlaag ↓
  2. De_Vloek 18 juli 2024 14:49
    quote:

    Diegy schreef op 18 juli 2024 14:41:

    [...]
    Straks om 15.00 uur een conference call? Als daar nog wat positiefs word gezegd dan krijgen we zeker nog een spike omhoog.
    Om 15:00 wordt het gepubliceerde bericht van vanochtend toegelicht. Opvolgend door een Q&A voor de aandeelhouders. Hier zal de financiering hopelijk een aanzienlijk deel van zijn.
  14. RESEARCH 18 juli 2024 21:52
    Blijf het bijzonder vinden. Toen bekend werd dat het middel voor Alzheimer geen effect had (waar enige tijd daarvoor men nog super positief was) komt men nu ineens aanzetten met verbetering van de nierfunctie. Was toen zeker niet bekend. Leuk fonds om ritjes mee te maken maar is geen serieuze belegging. Bestuur is onbetrouwbaar is de afgelopen jaren wel gebleken.
  16. SRD 19 juli 2024 08:41
    quote:

    RESEARCH schreef op 18 juli 2024 21:52:

    Blijf het bijzonder vinden. Toen bekend werd dat het middel voor Alzheimer geen effect had (waar enige tijd daarvoor men nog super positief was) komt men nu ineens aanzetten met verbetering van de nierfunctie. Was toen zeker niet bekend. Leuk fonds om ritjes mee te maken maar is geen serieuze belegging. Bestuur is onbetrouwbaar is de afgelopen jaren wel gebleken.
    Uit de webcast blijkt dat ze dat al tenminste 1-2 jaar hebben bestudeerd. Zoals ik al eerder heb gezegd verbaast mij dat niet. in beide gevallen gaat het om het voorkomen van de vorming van proteine "plaque". Past helemaal in het beeld van DKD. De resultaten zijn overtuigend. Wat mij nog niet helemaal duidelijk is om hoeveel patienten van de subgroep Diabetes 1/2 het gaat. Jammer dat de klinische studie fase 2 ook weer 2,5 jaar gaat duren.
  17. forum rang 10 DeZwarteRidder 19 juli 2024 12:15
    Vivoryon Therapeutics N.V. Announces New Data Showing Unique Treatment Effects of Varoglutamstat on Kidney Function in Patients with Diabetes and Outlines Proposed Clinical Development Plan in Diabetic Kidney Disease

    18 Jul 2024 07:00 CEST
    Issuer

    VIVORYON THERAPEUTICS N.V.

    Vivoryon Therapeutics N.V. Announces New Data Showing Unique Treatment Effects of Varoglutamstat on Kidney Function in Patients with Diabetes and Outlines Proposed Clinical Development Plan in Diabetic Kidney Disease

    New data confirm beneficial treatment effect of varoglutamstat on kidney function

    Treatment effect1 in diabetes subgroup2 of >8mL/min/1.73m2/year in estimated glomerular filtration rate (eGFR); reinforces previously reported treatment effect of 3.4mL/min/1.73m2/year (p<0.001) in the overall VIVIAD Phase 2b study population

    Excellent tolerability profile with no meaningful difference in adverse events between overall population and diabetes subgroup

    Additional health benefits including promising effects on weight loss, diastolic blood pressure and liver enzymes observed in diabetes subgroup

    New proposed Phase 2 clinical development plan for varoglutamstat in diabetic kidney disease announced

    Analyst/Investor call & webcast today, July 18, 2024, at 3:00 pm CEST / 9:00 am EDT

    Halle (Saale) / Munich, Germany, July 18, 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 that it will provide updates on its progress towards developing its lead asset varoglutamstat, an investigational QPCT/L inhibitor, in kidney disease during an R&D update call and webcast. The update includes new kidney function analysis in a diabetes subgroup from the VIVIAD Phase 2b study of varoglutamstat in Alzheimer’s disease, as well as the Company’s proposed development plan for varoglutamstat in its initial target indication, diabetic kidney disease (DKD).

    “The extremely promising data we are presenting today in a diabetes subgroup build on the strong body of evidence in the overall VIVIAD study population, where we observed a robust beneficial effect of varoglutamstat on kidney function,” said Frank Weber, MD, CEO of Vivoryon. “Specifically, new analysis reveals a significant and unique treatment effect in patients with diabetes which is coupled with additional potential health benefits on weight and blood pressure, and an excellent safety profile. Given these compelling results, we plan to advance varoglutamstat into a Phase 2 clinical study in patients with diabetic kidney disease, specifically in more advanced patients with a high risk of end stage kidney disease where there continues to be a significant unmet need for new therapies to stabilize and protect kidney function.”

    R&D Update: Key Highlights

    Significant Effect of Varoglutamstat in Diabetes Subgroup2

    New analysis of eGFR, a measure of kidney function, in a subgroup of patients with diabetes1 in the VIVIAD Phase 2b study reveals a substantially higher treatment effect3 of >8mL/min/1.73m2/year (p=0.02; varoglutamstat n=20 / placebo n=12) compared to the overall VIVIAD study population where the treatment effect was 3.4mL/min/1.73m2/year (p<0.001; varoglutamstat n=141 / placebo n=117).
    Promising additional effects observed in the diabetes subgroup in varoglutamstat treated patients included
    a reduction in liver transaminases (AST/ALT4 reduction of 6 units average)
    a mild weight loss (- 4kg)
    a reduction in diastolic blood pressure (- 6 mmHg)
    All results reported were observed at 48 weeks of treatment versus baseline. Similar observations were not made in the placebo group nor in the overall VIVIAD study population.
    Data revealed that the positive effect on kidney function in the diabetes subgroup appears to be independent of any change in glycemic control (HbA1C remained steady over the period for the varoglutamstat group).
    A reduction of the plasma concentration of the inflammatory and fibrosis inducing pE-CCL2 (p=0.004) was observed in the varoglutamstat arm, indicating a strong anti-inflammatory effect.
    Varoglutamstat was well-tolerated at the dose tested (up to 600mg twice daily) and there were no meaningful differences in adverse events observed in renal and metabolic system organ classes versus placebo or the total population.

    Proposed Clinical Development Plan in Diabetic Kidney Disease5

    Despite advances in the standard of care for DKD, there remains a significant unmet need for new therapies to stabilize kidney function and prevent disease progression.
    Vivoryon plans to start a Phase 2 study in DKD that is intended to include patients with disease stages more advanced than those observed in the VIVIAD Phase 2 study, enabling an expansion of the overall target patient population. The Company envisages a placebo-controlled study of up to approximately 120 subjects with stage 3b/4 DKD and >100mg/g albuminuria/proteinuria. These subjects would be randomized 1:1 to varoglutamstat 600mg twice daily or placebo, on top of standard of care medications. Key endpoints are planned to include eGFR slope analysis, measures of albuminuria (UA(p)CR), inflammation and fibrosis-related biomarkers, as well as safety.

    Collaborating with Key Experts to Advance Development Strategy

    The Company is collaborating with medical advisors and industry leaders to further shape its shift towards inflammatory/fibrotic disease, including:

    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), Germany. Acting as Medical Advisor for clinical study design. Research collaboration with Vivoryon focusing on pre-clinical and mechanistic activities relating to varoglutamstat and the role of QPCT/L on kidney function.
    Florian Jehle - CEO of Vifor-FMC Renal Pharma. Acting as Industry Expert Advisor to Vivoryon in the kidney field including strategic business and commercial advice.
    Kevin Carroll, PhD - CEO, KJC Statistics. Acting as statistical analysis expert, providing and calculating statistical read-outs and advising on clinical study statistical aspects.

    Detailed data and the Company's plans will be presented during the R&D update call, with the presentation available on the Vivoryon website during and after the event.

    Definitions and notes: 1. Treatment effect – the between-group difference in eGFR slope between varoglutamstat and placebo. 2. Estimated glomerular filtration rate (eGFR), a validated measure of kidney function, was calculated as a slope analysis across two years taking all available data into account. 3. Diabetes subgroup 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 > 6.5%. 4. AST: Aspartate Aminotransferase; ALT: Alanine Aminotransferase. 5. The timing and execution of the planned Phase 2 study is subject to additional funding / partnership.
2.798 Posts
Pagina: «« 1 ... 118 119 120 121 122 ... 140 »» | Laatste |Omhoog ↑

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