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

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DeZwarteRidder 19 juli 2024 13:17
   DeZwarteRidder

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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
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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.

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DeZwarteRidder 29 oktober 2024 08:59
   DeZwarteRidder

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Vivoryon Therapeutics N.V. Presents Outstanding Phase 2b Results of Varoglutamstat on Kidney Function at ASN Kidney Week 2024

Selected for late-breaking oral presentation at ASN kidney week, the world’s premier nephrology meeting
Results presented show a statistically significant and clinically meaningful improvement of the prospectively defined kidney function parameter eGFR1 by 3.4mL/min/year (p<0.0001) in the varoglutamstat arm compared to placebo
Results in the subgroup of patients with diabetes2 showed an 8.2mL/min/year difference in favor of varoglutamstat (p=0.02)
The results were consistent in several sensitivity analyses including using the CKD-EPI 2021 formula for both creatinine and cystatin-C
Varoglutamstat demonstrated an excellent safety and tolerability profile and there were no signs of increased proteinuria
A new Phase 2 study is in planning to confirm the effect in patients with DKD3 stage 3b and 4

Halle (Saale) / Munich, Germany, October 26, 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 highlights from a late-breaking oral presentation held yesterday, October 25, 2024, at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, California.

The presentation by the Company’s CEO, Frank Weber, M.D. titled “Varoglutamstat Increases Glomerular Filtration in Elderly Patients without Signs of Proteinuria and Potentially Offers a New Approach to Treat Diabetic Kidney Disease (DKD)” featured Phase 2 clinical study data substantiating the opportunity to further develop varoglutamstat, Vivoryon’s Phase 2 investigational medicine with the potential to improve kidney function, in people with kidney disease.

“We’re privileged to have been accepted to share the exciting results of varoglutamstat on kidney function with so many scientific and medical experts in the kidney field. Varoglutamstat showed statistically significant and clinically meaningful improvements of eGFR versus placebo and a sustained improvement of eGFR above baseline, potentially indicating partial recovery of the kidney. We are grateful for many fruitful discussions and extremely encouraged by the positive reactions we received from the community,” said Frank Weber, M.D., CEO of Vivoryon. “The efficacy and safety data presented at ASN represent a unique profile for an oral product for treating kidney disorders and guide the future development of varoglutamstat. Our primary focus is delivering a much-needed novel treatment option for patients suffering from DKD. Beyond this, we see potential for varoglutamstat across a broad range of kidney diseases including rare diseases affecting kidney function, such as Fabry disease and Alport syndrome.”

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