Vivoryon Therapeutics N.V. Highlights H1 2024 Kidney Function Data and Varoglutamstat Strategy Progress

Vivoryon Therapeutics N.V., a clinical stage company, has reported significant progress in the first half of 2024, particularly with its investigational medicine, varoglutamstat, which is in Phase 2 trials. The company is primarily focused on improving kidney function in patients with kidney disease.

Key highlights from the VIVIAD Phase 2b study in Alzheimer’s Disease (AD) showed varoglutamstat’s significant benefits for kidney function, specifically through the endpoint of estimated glomerular filtration rate (eGFR). This has led Vivoryon to pivot their strategy towards focusing on inflammatory and fibrotic diseases, with a particular interest in diabetic kidney disease (DKD).

Varoglutamstat demonstrated a considerable positive impact on kidney function, achieving a statistically significant increase in eGFR and a reduction in the pro-inflammatory cytokine pE-CCL2. The drug's benefits were notably amplified in a subgroup of diabetic patients, where the treatment effect on eGFR was more pronounced, thereby encouraging plans for a Phase 2 study in DKD.

Vivoryon’s CEO, Dr. Frank Weber, emphasized the strong progress made in understanding varoglutamstat’s pharmacokinetics and biomarkers, reinforcing the drug’s potential in treating kidney diseases. The VIVIAD data revealed that varoglutamstat not only has an excellent safety and tolerability profile but also supports the potential of QPCTL inhibitors in managing inflammatory and fibrotic diseases.

Key priorities moving forward include preparing for the proposed Phase 2 DKD study, concluding the VIVIAD Phase 2b study, analyzing data from the VIVA-MIND Phase 2 study in early AD, and pursuing business development and financing opportunities to further advance their research.

From a mechanistic perspective, varoglutamstat inhibits QPCT and QPCTL enzymes, which play a significant role in the formation of pyroglutamate, a post-translational modification linked to various diseases such as neurodegenerative, inflammatory, and fibrotic disorders, and cancer. This inhibition has shown efficacy in animal models of inflammatory and fibrotic disorders.

In the VIVIAD study, varoglutamstat notably increased eGFR over a treatment period of up to 96 weeks in early AD patients, indicating a potential benefit for kidney function. Sensitivity analyses confirmed this effect across different eGFR levels at baseline. Furthermore, varoglutamstat significantly reduced levels of pE-CCL2, reinforcing its anti-inflammatory properties.

In the diabetes subgroup of the VIVIAD study, varoglutamstat showed an even greater effect on eGFR. Additional benefits observed included reductions in liver transaminases, mild weight loss, and lower diastolic blood pressure. Importantly, these kidney function improvements appeared independent of changes in glycemic control, suggesting a direct impact of varoglutamstat on kidney health.

Vivoryon's proposed clinical development plan for DKD includes a Phase 2 study with around 120 subjects in advanced stages of the disease. This placebo-controlled study will measure key endpoints such as eGFR slope analysis, albuminuria, inflammation, and fibrosis-related biomarkers, ensuring a comprehensive evaluation of the drug’s efficacy and safety.

The financial results for the first half of 2024 showed no revenues, with research and development expenses increasing to EUR 10.3 million, driven by clinical development costs. General and administrative expenses decreased slightly to EUR 3.5 million. The company reported a net loss of EUR 13.6 million and held EUR 15.3 million in cash as of June 30, 2024.

Looking ahead, Vivoryon anticipates its existing cash reserves will fund operations into the second quarter of 2025, with continued efforts to secure additional funding crucial for its long-term viability and further research activities, particularly in kidney disease.

Vivoryon has also scheduled a virtual Kidney Disease KOL webcast for September 30, 2024, to provide detailed insights into varoglutamstat’s potential in treating kidney disease, focusing on DKD. The event will feature experts discussing current standards of care, unmet medical needs, market potential, and the latest research findings in kidney disease drug development.

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