• In March 2024, Vivoryon announced topline data for VIVIAD. The study, which
evaluated varoglutamstat up to 600mg BID, did not meet its primary endpoint of a
statistically significant difference in cognitive improvement over time, assessed by the
combined Z-score of the three elements of the Cogstate 3-item scale, as well as key
secondary endpoints measuring cognition and function including the Cogstate Brief
Battery (CBB); complete Cogstate neuropsychological test battery (NTB); the
Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q) and
electroencephalogram (EEG) global theta power.
• Safety results from the study showed that varoglutamstat was generally well tolerated
and showed rates similar to placebo of serious and severe treatment emergent adverse
events (TEAEs), low discontinuation rates due to adverse events and no evidence of
symptomatic ARIAs (amyloid-related imaging abnormalities) in the clinical setting.
• Vivoryon is conducting an in-depth analysis of the VIVIAD data. While these analyses
remain ongoing, findings to date confirm the topline results. Additionally, no statistically
significant or clinically meaningful effect of varoglutamstat up to 600mg BID was
observed on pre-specified subgroups. The only significant difference observed in favor
of varoglutamstat was a lower change from baseline in the WAIS IV coding test and the
letter fluency test, both measuring cognitive dysfunction, at week 48. Pharmacokinetic
and QPCT/L enzyme inhibition data in VIVIAD were consistent with previous results.
VIVIAD study – results from kidney function exploratory analyses
• The VIVIAD protocol prospectively specified measurement of certain kidney function
biomarkers. This was in line with the Company’s previously announced growth strategy
to explore varoglutamstat’s potential effects on kidney function.
• Varoglutamstat 600mg BID increased the estimated glomerular filtration rate (eGFR)
over the treatment period up to 96 weeks, indicating a potential benefit of
varoglutamstat on kidney function. Analysis is ongoing including a closer analysis of
VIVIAD results in patients with different eGFR levels at baseline.
• Given these statistically significant and clinically meaningful data, Vivoryon is
evaluating a development path including business development and financing
opportunities to further explore the potential of varoglutamstat and QPCT/L inhibitors
in kidney disease.
VIVA-MIND study in early AD
VIVA-MIND (NCT03919162) is a Phase 2 study conducted in the U.S. evaluating the safety,
tolerability, and efficacy of varoglutamstat in patients with early AD.
• Vivoryon announced today that, based on the ongoing review of VIVIAD data published
March 4, 2024, and an assessment of funding needs, the Company has decided jointly
with its principal investigator, to voluntarily discontinue the Phase 2 VIVA-MIND study
in early AD in the U.S. in the second half of 2024. This will enable accelerated analysis
of the results and will contribute to the overall dataset informing varoglutamstat’s