New analysis of data from varoglutamstat Phase 2 program for patients with lower baseline eGFR shows consistent and pronounced treatment effect, further supporting plans to advance development in stage 3b/4 DKD
Compelling kidney function data from VIVIAD Phase 2b study presented in late-breaking poster session at ASN kidney week, the world's premier nephrology meeting
Successful completion of private placement supported by existing and new shareholders raising EUR 5.1 million; extends cash runway well into Q3 2026, providing financial runway and flexibility to realize strategic partnership
Management to host conference call today at 3:00 pm CET (9:00 am EST)
Halle (Saale) / Munich, Germany, December 4, 2025 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the nine-month period ended September 30, 2025, and provided a corporate update.
"The third quarter of 2025 and year to date have been marked by continued advancements towards realizing the full potential of varoglutamstat, including successfully completing a capital raise that provides us with financial runway and flexibility to advance our strategic objectives," said Frank Weber, MD, CEO of Vivoryon. "Our recent analyses of VIVIAD/VIVA-MIND data continue to underscore the unique potential of varoglutamstat to meaningfully improve kidney function in patients with diabetes. A new analysis was conducted across patients with different eGFR baseline levels, which indicate different degrees of kidney function impairment, to evaluate how patients with impaired kidney function respond to varoglutamstat. Here, we saw a consistent and pronounced treatment effect across all patients and, importantly, we also saw this effect in patients with more impaired kidney function, as indicated by low baseline eGFRs. These results give us further confidence in our plan to advance varoglutamstat into a Phase 2b study in stage 3b/4 diabetic kidney disease." He concluded, "Building on the beneficial effects on inflammation and fibrosis that we are observing with varoglutamstat, we see potential for this promising drug class to be relevant across a broader range of immune-mediated diseases. Here, our core expertise and differentiated platform of oral small-molecule QPCT/L inhibitors allow us to selectively explore additional development and partnership opportunities alongside our primary focus of advancing the DKD program."
Q3 2025 and Post-Period Updates
Varoglutamstat Clinical Program
Vivoryon's varoglutamstat Phase 2 program has shown highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studies. The Company is planning to confirm the previously reported compelling data from its two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a dedicated Phase 2b clinical study in patients with diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.
VIVIAD study data shows consistent treatment effect across eGFR levels in the lower eGFR percentiles
New analysis of pooled data from Vivoryon's varoglutamstat Phase 2 program revealed a consistent treatment effect in both the total population and in patients with diabetes.
In patients with diabetes within the lower eGFR percentiles (50%/ 33.3%/ 25%/ 20%), mean eGFR baseline levels ranged from 65-56 mL/min/1.73m2 and the treatment effect was in the range of 5.3-7.7 mL/min/1.73m2/year.
These results further support Vivoryon's rationale for a dedicated Phase 2b clinical study in patients with advanced DKD stage 3b/4.
VIVIAD study data presented at ASN
On ...
