Vivoryon Therapeutics N.V. Provides Comprehensive Progress Report for Ongoing Varoglutamstat Clinical Program Following R&D Event and VIVA-MIND DSMB Dose Decision

Vivoryon Therapeutics N.V. Provides Comprehensive Progress Report for Ongoing Varoglutamstat Clinical Program Following R&D Event and VIVA-MIND DSMB Dose Decision

• Both VIVIAD and VIVA-MIND progressing at 600mg twice daily with oral administration following two independent positive DSMB decisions
• Varoglutamstat demonstrates very encouraging safety data with no evidence of drug-related ARIAs at therapeutic dose of 600mg twice daily, a dose demonstrated to result in nearly 90% target occupancy
• On track to report final VIVIAD Phase 2b readout in Q1/2024
• Commenced preparations for open label extension study to provide long-term treatment option to patients after completion of treatment under VIVIAD or VIVA-MIND
• Company to participate at upcoming Jefferies London Healthcare Conference taking place November 14-16, 2023
  
  

Halle (Saale) / Munich, Germany, October 26, 2023 – 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 provided a comprehensive overview of the progress of the ongoing clinical development of varoglutamstat, an orally administered novel small molecule. Varoglutamstat’s mid to late-stage clinical studies, VIVIAD and VIVA-MIND, evaluating its potential to treat early Alzheimer’s disease (AD), are comprised of a broad range of key primary and secondary endpoints covering cognition, function and neuronal connectivity.

“The breadth and significance of data collected thus far from varoglutamstat’s clinical development program further expands our understanding of early AD pathology and treatment. With independent DSMB dose decisions for both of our ongoing Phase 2 studies across multiple geographies and different titration regimens, varoglutamstat, has been cleared from a safety and tolerability standpoint to proceed with the highest investigated dose of 600mg twice daily. By evaluating varoglutamstat in two parallel clinical studies with varying efficacy endpoints, we can meaningfully support our regulatory strategies and provide a clear picture of the cognitive changes potentially resulting from treatment on study. Utilizing a stepwise methodology for clinical development, we have been able to create a statistically robust trial setting in VIVIAD with the intent of VIVA-MIND designed to confirm the findings of VIVIAD,” said Frank Weber, M.D., CEO of Vivoryon. “Building upon the positive findings from the SAPHIR Phase 2a study, we have meticulously designed VIVIAD and VIVA-MIND, grounded in the understanding that N3pE-Abeta presence has been identified in and beyond plaques, in the synaptic space of neurons and within their cell walls. Varoglutamstat has shown convincing results of neuronal recovery after only 12 weeks of treatment, which supports our belief in the advantages of this mechanism of action to substantially reduce the production of N3pE-Abeta, rather than increase the clearance once synthesized and deposited in the plaque. Together, SAPHIR, VIVIAD and VIVA-MIND culminate in an immensely comprehensive Phase 2 clinical development program in early AD conducted so far with a planned total of nearly 800 patients. The program is further supported by varoglutamstat’s Fast Track designation granted by the FDA. Vivoryon is committed to improving the daily lives of patients with early AD and their families and we look forward to our imminent, final study readout from VIVIAD in the first quarter of 2024 at which point we intend to share final topline data, with the full dataset to be presented at a subsequent medical meeting.”