Netherlands-based Vivoryon Therapeutics has provided updates on its clinical development programme for varoglutamstat for treating Alzheimer’s disease (AD), including clinical trial data.
Varoglutamstat is an N3pE-amyloid-targeting small molecule with disease-modifying potential. It is currently in two Phase II trials, VIVIAD (NCT04498650) and VIVA-MIND (NCT03919162) in Europe and the US, respectively. The final data readout for the VIVIAD trial in Europe is expected in the first quarter of 2024 and the company intends to provide a study update for VIVA-MIND in the fourth quarter of 2023.
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Vivoryon CEO Dr Ulrich Dauer said in a press release: “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.
“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.”
Vivoryon also reported initiating preparations for an open-label extension study to investigate long-term outcomes for patients treated under VIVIAD or VIVA-MIND protocols. However, the study launch is contingent on outcomes of the VIVIAD trial.
Varoglutamstat VIVIAD clinical data
The data from the multicentre, placebo-controlled Phase IIb trial for varoglutamstat in patients with mild cognitive impairment (MCI) and mild AD showed no clinical signs of Amyloid-related imaging abnormalities (ARIA) as of the cutoff date of 14 June 2024.
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By GlobalDataThe 259 participants also reported lower discontinuation rates for twice-daily 800mg varoglutamstat compared to participants in the previous Phase IIa trial (NCT02389413).
This safety profile led to the independent Data Safety Monitoring Board’s (DSMB) decision to continue the study as it is, without any additional modifications.
The primary endpoint for the study is a composite of the Neuropsychological Test Battery (NTB), which assesses five cognitive domains, namely attention, language, memory, spatial, and executive functions. A special focus will be placed on working memory and attention.
The secondary endpoints include multiple assessments for cognitive, safety, and biomarkers.
Varoglutamstat VIVIAD-MIND update
Vivoryon reported the completed enrolment and randomisation for the first cohort for the US Phase II VIVA-MIND study. Enrolment for the second cohort is now open for 19 of the US sites.
The company reiterated that the final decision regarding the trial size for VIVA-MIND will be based on VIVIAD’s data readout, and to expect a study update in the last quarter of 2023.
The study’s primary endpoint is a clinical dementia rating scale to measure cognitive abilities and activities of daily living. Secondary endpoints include recognised and exploratory quantitative cognitive assessments.
Updated 27 July 2023.
