Vivoryon Therapeutics N.V. Reveals Phase 2 Data Supporting Varoglutamstat’s Potential for Kidney Function Improvement

Vivoryon Therapeutics N.V., a clinical-stage company, has unveiled positive topline data from its U.S. VIVA-MIND study of varoglutamstat (PQ912), an investigational drug for early Alzheimer’s disease (AD). This Phase 2 study was designed to evaluate the impact of varoglutamstat on estimated glomerular filtration rate (eGFR), a key marker of kidney function. Results indicate a statistically significant improvement in eGFR by more than 4mL/min/1.73m² among those treated with varoglutamstat compared to the placebo group across all visits and patients (weighted average weeks 4-72; p<0.001).

Although the VIVA-MIND study was discontinued early and did not meet its primary and secondary endpoints in early AD, in line with prior results from the VIVIAD study, the findings continue to support the positive effect of varoglutamstat on kidney function. The improvement in eGFR observed in VIVA-MIND complements the previously reported benefits from the completed Phase 2b VIVIAD study, reinforcing the potential of varoglutamstat in treating kidney-related conditions.

Vivoryon's CEO, Frank Weber, M.D., emphasized the importance of replicating results in multiple high-quality studies. He noted that the consistent and meaningful improvement in kidney function observed in the VIVA-MIND study supports the findings from VIVIAD and the company's intention to further explore varoglutamstat's therapeutic potential in diabetic kidney disease (DKD). Despite the disappointing AD outcomes, the safety profile of varoglutamstat continues to be favorable, with no new safety signals detected.

The VIVA-MIND study, managed by the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine and funded by the National Institutes of Health (NIH), initially aimed to enroll a total of 414 patients. However, based on negative outcomes from the VIVIAD study, it was discontinued early to expedite data analysis and refine the development strategy for varoglutamstat. Consequently, only 112 patients were recruited, and 109 treated in the Phase 2a portion of the study.

Varoglutamstat, a potent and selective inhibitor of human glutaminyl cyclases QPCT and QPCTL, has demonstrated a favorable safety and tolerability profile in various clinical studies involving both healthy volunteers and AD patients. The investigations revealed significant improvements in kidney function and reductions in kidney inflammation biomarkers, particularly in a post-hoc diabetes subgroup. These findings prompted plans to advance varoglutamstat into a Phase 2 study for DKD.

Vivoryon Therapeutics N.V., headquartered in Halle (Saale) and Munich, Germany, is dedicated to developing small molecule-based medicines that modulate the activity and stability of proteins altered in disease settings. The company's pipeline includes treatments for Alzheimer’s disease, inflammatory and fibrotic disorders, and cancer.

Further details on the topline results from the VIVA-MIND study will be shared during Vivoryon’s Q3 financial results webcast on December 10, 2024. The webcast will provide more insights into the company's progress and operational updates.