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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 (p0.0001), with an even more substantial 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.
Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY) will host an R&D update call on July 18, 2024, at 3:00 pm CEST / 9:00 am EDT, focusing on advancements in kidney disease treatment. The conference will detail further analyses and data on varoglutamstat's beneficial effects on kidney function, along with updates on its clinical development plan. Participants can join via phone or webcast, with a live audio stream available on Vivoryon's website. The event will include a Q&A session for investors and analysts. Pre-registration is required for phone access, and a replay will be available post-presentation.
Vivoryon Therapeutics N.V., a clinical-stage company focused on small molecule medicines, held its 2024 Annual General Meeting (AGM) on June 21 in Halle (Saale) / Munich, Germany. Shareholders approved all proposed items on the agenda. The event, held at 1:00 p.m. (CEST), included a presentation by the management team. Key details and related documents regarding the AGM are accessible on the company's website.
Vivoryon Therapeutics N.V. reported financial results for Q1 2024, highlighting a strategic shift towards kidney disease following disappointing AD study results. The company observed substantial improvements in kidney function with varoglutamstat. Revenue remained zero, but R&D and administrative expenses rose, leading to a net loss of EUR 9.3 million. Cash reserves stood at EUR 22.0 million, expected to fund operations into Q2 2025. Vivoryon will focus on inflammatory and fibrotic disorders and plans to discontinue the VIVA-MIND study. The 2024 Annual General Meeting is set for June 21 in Amsterdam.