Vivoryon Therapeutics N.V. Presents Topline Phase 2 Data from VIVA-MIND Strongly Supporting Varoglutamstat’s Potential to Improve Kidney Function
09 Dec 2024 07:00 CET
Issuer
VIVORYON THERAPEUTICS N.V.
Vivoryon Therapeutics N.V. Presents Topline Phase 2 Data from
VIVA-MIND Strongly Supporting Varoglutamstat’s Potential to
Improve Kidney Function
VIVA-MIND Phase 2 data confirm results of varoglutamstat’s benefit on eGFR in VIVIAD; Company now has two independent double-blind placebo-controlled Phase 2 studies demonstrating a clinically meaningful treatment effect on kidney function
Topline analysis of kidney function data in VIVA-MIND shows a statistically significant and clinically meaningful improvement of eGFR; average improvement of >4mL/min/1.73m2 with varoglutamstat versus placebo across all visits (weeks 4–72) and all patients (p<0.001)
VIVA-MIND, a Phase 2 study in early Alzheimer’s disease (AD), was discontinued early and did not meet its primary and key secondary endpoints in early AD, in line with the previously reported results from VIVIAD
Varoglutamstat continues to demonstrate a favorable safety and tolerability profile in VIVA-MIND with no new safety signals detected and a total of over 400 participants treated with varoglutamstat in Phase 1 and Phase 2 studies to date
Further detail on the topline results from VIVA-MIND to be shared in the Company’s Q3 financial results webcast to be held on December 10, 2024, at 3:00 pm CET
Halle (Saale) / Munich, Germany, December 9, 2024 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced positive Phase 2 topline data from its U.S. VIVA-MIND study of varoglutamstat (PQ912), an investigational oral glutaminyl cyclase (QPCT/L) inhibitor, in early AD. Analysis of kidney function data revealed a statistically significant improvement of >4mL/min/1.73m2 in the estimated glomerular filtration rate (eGFR) in patients treated with varoglutamstat 600mg BID versus placebo across all visits and all patients (weighted average weeks 4-72; p<0.001; total treated n=109; varoglutamstat n=52, placebo n=57). Analysis of eGFR was prospectively defined as a safety parameter in VIVA-MIND. These data reinforce the previously reported beneficial effect of varoglutamstat on eGFR in the completed Phase 2b VIVIAD study and support the Company’s development strategy to advance into a Phase 2 study in diabetic kidney disease (DKD)1.
“In clinical development it is highly relevant to replicate results in two independent high-quality studies. The topline VIVA-MIND data showed a consistent, statistically significant and clinically meaningful improvement of kidney function, as measured by eGFR, in patients treated with varoglutamstat versus placebo and clearly corroborate previously reported results from VIVIAD,” said Frank Weber, M.D., CEO of Vivoryon.
Analysis of VIVA-MIND data in AD showed no clinically meaningful and no statistically significant differences between varoglutamstat 600mg BID and placebo for the primary endpoint of CDR-SB, and key secondary endpoints including CFC2, ADAS-Cog 13, in patients treated with varoglutamstat compared to placebo, in line with the previously reported results in AD from VIVIAD.
Frank Weber continued, “As for the results in AD, these confirm the data seen in VIVIAD and are therefore not unexpected. While we would have wished for a different outcome of this study, we would like to thank all patients, their families and caregivers, the Alzheimer's Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine and clinical study investigators as well as the U.S. National Institutes of Health – enabling the VIVA-MIND study through a grant – for their commitment to the study and the varoglutamstat program.”
VIVA-MIND met its safety endpoints with varoglutamstat being generally well tolerated with no new safety signals observed at the 600mg BID dose.
All topline VIVA-MIND results are preliminary and may be subject to change based on additional analysis and quality checks, however, the overall interpretation of the results is not expected to change significantly.
The Company will provide further detail on the topline VIVA-MIND data on December 10, 2024, in its Q3 financial results webcast.