Vivoryon Therapeutics N.V. Shares Clinical Development Update Highlighting Progress of N3pE-Amyloid-targeting Small Molecule Varoglutamstat in Alzheimer’s Disease - Seite 2

“In light of the renewed momentum within the Alzheimer’s disease drug development space with the first full approval of a potentially disease-modifying medication, I am particularly encouraged by the opportunity to be testing varoglutamstat within our Phase 2 Proof-of-Concept trial,” commented Dr. Howard Feldman, Professor of Neurosciences and Director of the ADCS at UC San Diego School of Medicine, and the VIVA-MIND study director. “As a small molecule alternative that can conveniently be taken at home and potentially without comparable risks of brain swelling and bleeding seen with amyloid lowering monoclonal antibodies, varoglutamstat may hold significant advantages in safety and ease of use by patients.”

“As varoglutamstat continues to progress through clinical development, we are very pleased to report that VIVIAD’s independent Data Safety Monitoring Board has determined that the VIVIAD study can continue without modifications and no additional meetings will be required until the meeting scheduled at study completion,” added Dr. Ulrich Dauer, CEO of Vivoryon. “This is the first time varoglutamstat long-term safety data from patients suffering from Alzheimer’s disease with a treatment duration of more than a year and up to two years have been reviewed independently. Our path forward both from a clinical and regulatory perspective is promising and we see the outcomes of this meeting as an important point of validation for our approach. The growing evidence supporting varoglutamstat as a potential novel medicine to treat Alzheimer’s disease with a favorable safety profile is incredibly encouraging, particularly as we think about its positioning within the broader treatment landscape. We look forward to reporting on the final data, which we expect to read out in the first quarter of 2024. In tandem, given the excellent progress of VIVIAD, we have decided to initiate preparations for an open label extension study, which, following positive VIVIAD study outcome, could provide a long-term therapeutic option to patients who have been treated under VIVIAD or VIVA-MIND protocols.”

Varoglutamstat Clinical Program:

Varoglutamstat is a differentiated investigational small-molecule medicine in development to treat Alzheimer’s disease. It is currently being investigated in two large Phase 2 studies, VIVIAD (NCT04498650) in Europe and VIVA-MIND (NCT03919162) in the U.S., where it continues to show evidence of a favorable safety profile at the therapeutic dose of 600 mg twice daily (BID), a dose demonstrated to result in a target occupancy of nearly 90%.