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Vivoryon Therapeutics N.V. (symbol: VVY) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic solutions for age-related diseases. The company focuses primarily on combating neurodegenerative conditions such as Alzheimer's disease. The core business of Vivoryon involves the research and development of drug candidates that target specific enzymes implicated in the pathogenesis of these diseases.
One of the company's flagship projects is the development of varoglutamstat (PQ912), a first-in-class therapy aimed at inhibiting the enzyme glutaminyl cyclase (QC). This enzyme is known to play a significant role in the formation of toxic proteins associated with Alzheimer's disease. Vivoryon's approach is designed to slow down or halt disease progression by reducing the build-up of these harmful proteins.
Recent achievements include the successful completion of Phase IIb clinical trials for varoglutamstat, which demonstrated promising efficacy and safety profiles. The company is now gearing up for Phase III trials and has received positive feedback from regulatory authorities.
In addition to varoglutamstat, Vivoryon is exploring other therapeutic candidates and biomarkers that could potentially address various aspects of neurodegenerative and age-related disorders. The company's robust pipeline showcases its commitment to expanding its portfolio through both in-house research and strategic partnerships.
Financially, Vivoryon maintains a strong position with a diversified funding strategy that includes grants, partnerships, and equity financing. The company's recent financial results highlighted steady progress in R&D expenditures, reflecting its focused investment in advancing its clinical programs.
Vivoryon collaborates with leading academic institutions and industry partners to leverage cutting-edge research and technology. These partnerships are crucial for accelerating the development of its therapeutic candidates and ensuring access to the latest scientific advancements.
Overall, Vivoryon Therapeutics N.V. is at the forefront of developing new treatments for age-related diseases, with a particular focus on neurodegeneration. Its innovative approach, strong financial health, and strategic partnerships position the company as a significant player in the biopharmaceutical industry.
Vivoryon Therapeutics reported Q3 2024 results and significant progress with varoglutamstat in kidney disease treatment. Two independent Phase 2 studies (VIVA-MIND and VIVIAD) demonstrated statistically significant improvement in kidney function. The VIVIAD study showed eGFR improvement of 3.4mL/min/1.73m2/year versus placebo, with even stronger results in diabetic patients (8.2mL/min/1.73m2/year).
The company plans to initiate a Phase 2 study in Diabetic Kidney Disease (DKD), pending additional funding or partnership. Financial results show R&D expenses increased to EUR 12.6 million, while G&A expenses decreased to EUR 4.9 million. Cash position stands at EUR 12.5 million as of September 30, 2024, with runway extended into Q3 2025.
Vivoryon Therapeutics announced topline Phase 2 data from the VIVA-MIND study of varoglutamstat in early Alzheimer's disease. The study showed a statistically significant improvement in kidney function, with patients treated with varoglutamstat 600mg BID showing an average improvement of >4mL/min/1.73m2 in estimated glomerular filtration rate (eGFR) versus placebo (p<0.001).
However, the study did not meet its primary and key secondary endpoints for Alzheimer's disease treatment, aligning with previous VIVIAD study results. The drug maintained a favorable safety profile with no new safety signals detected across over 400 participants in Phase 1 and 2 studies. The company plans to advance into a Phase 2 study in diabetic kidney disease, subject to additional funding/partnership.
Vivoryon Therapeutics, a clinical stage company focused on developing small molecule medicines for modulating pathologically altered proteins, has announced it will release its Q3 2024 financial results and provide a corporate update on December 10, 2024.
The company will host a conference call and webcast at 3:00 pm CET / 9:00 am ET. The event will be accessible via phone through pre-registration and through a live audio webcast on Vivoryon's website. Participants are advised to join 15 minutes before the scheduled start time.
Vivoryon Therapeutics presented Phase 2b results for varoglutamstat at ASN Kidney Week 2024, showing significant kidney function improvements. The study demonstrated a 3.4mL/min/year improvement in eGFR compared to placebo (p<0.0001), with an even more substantial 8.2mL/min/year improvement in diabetic patients (p=0.02). The drug showed excellent safety and tolerability with no increased proteinuria. Based on these results, Vivoryon is planning a new Phase 2 study focusing on patients with Diabetic Kidney Disease (DKD) stages 3b and 4. The company also sees potential applications in rare kidney diseases like Fabry disease and Alport syndrome.
Vivoryon Therapeutics (Euronext Amsterdam: VVY) announced that its abstract on Varoglutamstat has been selected for a late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, California, from October 23 to 27. The abstract titled 'Varoglutamstat Increases Glomerular Filtration in Elderly Patients without Signs of Proteinuria and Potentially Offers a New Approach to Treat Diabetic Kidney Disease (DKD)' will be presented by Frank Weber, M.D., CEO, on October 25, 2024, at 5:40 PM PDT.
Varoglutamstat (PQ912) is a potent and selective inhibitor of human glutaminyl cyclases QPCT and QPCTL, with potential therapeutic applications in inflammatory and fibrotic diseases, neurodegenerative diseases, and cancer. Initially developed for Alzheimer's disease (AD), it has shown favorable safety and tolerability in various clinical studies. The Phase 2 VIVIAD study in AD included the investigation of kidney function to explore the role of QPCT/L inhibition on kidney function.
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 reported significant advancements in H1 2024, particularly with varoglutamstat, a Phase 2 drug showing notable improvements in kidney function for patients with kidney disease. The VIVIAD Phase 2b study highlighted a statistically significant benefit in eGFR and reduced pro-inflammatory cytokine pE-CCL2 levels. A significant benefit was also noted in diabetic subgroups, leading to plans for a Phase 2 study in diabetic kidney disease (DKD).
The company shifted focus to inflammatory and fibrotic diseases due to these results. Financially, Vivoryon reported a net loss of €13.6M for H1 2024 and a decrease in cash and equivalents to €15.3M.
Key upcoming events include a conference call and a virtual Kidney Disease KOL webcast to discuss the drug's potential further. The company is also seeking business development and financing opportunities to support its initiatives.
Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY) has completed a share capital reduction by decreasing the nominal value of its shares from €1.00 to €0.01. This change, approved by shareholders at the 2024 AGM, aims to:
- Improve the company's ability to attract new financing
- Pursue M&A activities
- Enhance incentives for management and employees through equity awards
- Improve the company's equity composition
The number of ordinary shares remains unchanged at 26,066,809. The €0.99 per share reduction has been added to the company's distributable reserves. Updated articles of association are now available on Vivoryon's website.
Vivoryon Therapeutics N.V. (VVY), a clinical stage company developing small molecule medicines for pathologically altered proteins, has announced two upcoming events in September 2024:
1. Half Year 2024 Results on September 12, 2024, at 3:00 pm CEST / 9:00 am EDT. The company will publish financial results and provide a corporate update. A conference call and webcast will be available to the public.
2. Virtual Kidney Disease KOL Event on September 30, 2024, at 3:00 pm CEST / 9:00 am EDT. Further details and participation information will be provided on the company's website.
Both events will be accessible via webcast on Vivoryon's website. For the half-year results call, participants can pre-register for dial-in details.
Vivoryon Therapeutics N.V. (VVY) announced new data showing unique treatment effects of varoglutamstat on kidney function in patients with diabetes. The company reported a significant treatment effect of >8mL/min/1.73m2/year in estimated glomerular filtration rate (eGFR) in the diabetes subgroup of the VIVIAD Phase 2b study. This effect was substantially higher than the 3.4mL/min/1.73m2/year observed in the overall study population.
Additional benefits observed in the diabetes subgroup included weight loss, reduced diastolic blood pressure, and decreased liver enzymes. Varoglutamstat demonstrated an excellent tolerability profile with no meaningful difference in adverse events between the overall population and the diabetes subgroup.
Vivoryon also outlined a proposed Phase 2 clinical development plan for varoglutamstat in diabetic kidney disease (DKD), targeting patients with more advanced disease stages.
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