Vivoryon Therapeutics N.V. Reports Q1 2023 Financial Results and Highlights Operational Progress

Vivoryon Therapeutics N.V. Reports Q1 2023 Financial Results and Highlights Operational Progress

Halle (Saale) / Munich, Germany, May 16, 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 announced financial results and corporate updates for the first quarter of 2023, ending March 31, 2023.

“In the first quarter of 2023, we continued to advance our lead program for Alzheimer’s disease, varoglutamstat, through both the VIVIAD and VIVA-MIND studies and reported further data demonstrating both strong tolerability and improvements in pathological hallmarks, synaptic function and connectivity, cognition, memory and attention in AD patients,” said Dr. Ulrich Dauer, CEO of Vivoryon. “Amidst steady clinical progress with varoglutamstat, we are also encouraged by the recent activity and developments in the broader AD treatment landscape, in particular the emerging clinical evidence validating our approach of targeting neurotoxic N3pE-Abeta. We believe we are well-positioned for varoglutamstat to provide an effective and much-needed therapeutic option that alleviates issues with administration for patients with this devastating disease. Vivoryon has an exciting year ahead and we look forward to reporting important safety updates later this year for our VIVA-MIND trial in the U.S. and final data from our VIVIAD study in the first quarter of next year.”

Q1 2023 and Post-Period Portfolio Highlights

Varoglutamstat Clinical Program:

• VIVIAD (NCT04498650) is a state-of-the-art Phase 2b study being conducted in Europe and designed to evaluate the safety, tolerability, and efficacy of varoglutamstat in 250 subjects with mild cognitive impairment (MCI) and mild Alzheimer’s disease (AD).
  • In March 2023, Vivoryon provided an update on varoglutamstat clinical development for the treatment of AD at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD). As of the data cut-off date of January 5, 2023, over 100 of the 259 participants randomized into the VIVIAD study had been treated for at least 48 weeks. Varoglutamstat showed no on-target toxicity and no clinical signs of brain swelling or hemorrhages (ARIA), which are a limiting class side effect of Abeta antibodies and has been well-tolerated in the study to date. Both the total number of SAEs and the discontinuation rate were considerably lower than the respective numbers at the 800 mg BID varoglutamstat dose in Vivoryon’s completed Phase 2a SAPHIR study, while retaining a similar level of target inhibition (around 90%) at the dosing in both studies.
  • Vivoryon remains on track to report the final data readout from the VIVIAD study in the first quarter of 2024.
• VIVA-MIND (NCT03919162) is a complementary Phase 2 study for varoglutamstat conducted in the U.S. which seeks to enroll 180 patients with early AD into the Phase 2a adaptive dose finding portion and enroll a further 234 patients in the Phase 2b portion of the study.
  • In March 2023, Vivoryon announced the study is ongoing and continuing to recruit patients at 18 sites across the U.S. The study’s independent DSMB recently provided a unanimous recommendation to continue the study without modification. The Company anticipates a decision on final trial size following the data readout of the VIVIAD study.
  • Vivoryon expects the first cohort to be fully randomized into the study within the second quarter of this year and plans to provide the next update on the VIVA-MIND study in the second half of 2023.