Vivoryon Therapeutics N.V. Reports Full Year 2023 Financial Results and Provides Varoglutamstat and Strategic Updates
A thorough analysis of the results from the VIVIAD Phase 2b study is ongoing, including pre-specified and exploratory endpoints; findings so far are consistent with the previously announced top-line data observing no statistically significant or clinically meaningful effect of varoglutamstat on cognition and function in early AD up to a 600mg twice a day (BID) dose. A statistically significant improvement in kidney function was observed with varoglutamstat 600mg BID in VIVIAD over two years based on a pre-specified analysis of the estimated glomerular filtration rate. The company plans to explore the potential of varoglutamstat in kidney disease by shifting its strategic focus towards inflammatory and fibrotic disorders. The VIVA-MIND Phase 2 study will be discontinued early, in the second half of 2024, which will enable accelerated data analysis and inform varoglutamstat’s development strategy. The company is taking steps to reduce cash utilization and will prioritize resources on exploring varoglutamstat in kidney disease, analyzing the VIVIAD and VIVA-MIND data, select pipeline programs, and continuing business development. Based on current financial and business plans, including the discontinuation of VIVA-MIND, the company’s cash runway is now expected to extend into the second quarter of 2025 without additional financing. Management will host a conference call today at 3:00pm CEST (9:00am EDT).
A thorough analysis of the results from the VIVIAD Phase 2b study is ongoing, including pre-specified and exploratory endpoints; findings so far are consistent with the previously announced top-line data observing no statistically significant or clinically meaningful effect of varoglutamstat on cognition and function in early AD up to a 600mg twice a day (BID) dose. A statistically significant improvement in kidney function was observed with varoglutamstat 600mg BID in VIVIAD over two years based on a pre-specified analysis of the estimated glomerular filtration rate. The company plans to explore the potential of varoglutamstat in kidney disease by shifting its strategic focus towards inflammatory and fibrotic disorders. The VIVA-MIND Phase 2 study will be discontinued early, in the second half of 2024, which will enable accelerated data analysis and inform varoglutamstat’s development strategy. The company is taking steps to reduce cash utilization and will prioritize resources on exploring varoglutamstat in kidney disease, analyzing the VIVIAD and VIVA-MIND data, select pipeline programs, and continuing business development. Based on current financial and business plans, including the discontinuation of VIVA-MIND, the company’s cash runway is now expected to extend into the second quarter of 2025 without additional financing. Management will host a conference call today at 3:00pm CEST (9:00am EDT).