Kuiken schreef op 28 maart 2023 09:18:
Halle (Saale) / Munich, Germany, March 28, 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 an update on both clinical studies of its lead candidate, varoglutamstat, a small molecule medicine in development for the treatment of Alzheimer's disease (AD), VIVA-MIND (NCT03919162) and VIVIAD (NCT04498650). Furthermore, the Company presents updated safety data from its European Phase 2b study, VIVIAD, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Gothenburg, Sweden.
“We are pleased to report that both of our ongoing studies are progressing steadily, and we continue to broaden the overall data package for varoglutamstat with consistently positive incremental results,” commented Dr. Ulrich Dauer, CEO of Vivoryon. “Varoglutamstat is strongly positioned as a differentiated oral, outpatient small molecule that has the potential to significantly impact the AD treatment landscape and address ongoing unmet need. Designed to modulate all major hallmarks of AD including Abeta aggregation, neuroinflammation and tau pathology, and also enabling improvement of synaptic function, varoglutamstat captures the key features of a novel drug that has already exhibited a favorable safety profile with no signs of ARIA side effects. We are incredibly encouraged by what we have been able to report to date, and we see a unique opportunity for ultimately realizing the promise of a widely accessible treatment option in AD with the realistic potential to reach the millions of patients in need.”
Vivoryon is pursuing a unique and highly differentiated approach to AD treatment, with a meticulously designed clinical development strategy. Grounded in the discovery that the enzyme glutaminyl cyclase (QPCT) catalyzes formation of the neurotoxic Abeta variant N3pE- Abeta, a key driver of AD pathology, Vivoryon is pioneering small molecule-based therapies to block this disease pathway. Varoglutamstat is designed to prevent N3pE- Abeta formation, rather than aiming to clear existing plaques, making it an intervention upstream of other approaches such as monoclonal antibodies (mAbs). Through a second mode of action, varoglutamstat also modulates neuroinflammation via the CCL2 pathway, which, in turn, has an impact on tau pathology.
“We are extremely encouraged by the exceptionally low discontinuation rates in both of our studies,” added Dr. Michael Schaeffer, CBO of Vivoryon. “Vivoryon is acutely focused on lessening the burden of AD for both patients and their families. As we are addressing an elderly patient population, we know how important it is to design a drug that is convenient. These patients typically have to live with and manage many different health conditions at the same time, which heavily impacts their everyday lives. Many feel overwhelmed by the sheer number of medicines they have to take every day and it is therefore our goal to make taking varoglutamstat as easy and convenient as possible. By investigating options to further optimize the formulation of our tablets, we feel that we have the unique chance to facilitate adherence to the correct dosing in our clinical studies and beyond.”
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