Wolfgang Miesbach: A Pivotal Step Forward for Patients with von Willebrand Disease Across All Subtypes
Wolfgang Miesbach, Professor of Medicine at Frankfurt University Hospital, shared a post on LinkedIn:
“A New Era for Von Willebrand Disease?
At the EAHAD 2026 Annual Congress, Gabriela Yamaguti-Hayakawa presented the Phase 1/2 multi-dose interim results of VIVID 3 – a pivotal step forward for patients with von Willebrand disease (VWD) across all subtypes.
The mechanism: VGA039 is a fully human, subcutaneous (SC) monoclonal antibody targeting Protein S – attenuating its cofactor function for TFPIα and activated protein C, thereby restoring thrombin generation during both initiation and propagation of coagulation.
A truly novel approach, independent of VWF replacement.
Once monthly SC dosing – with weight-banded fixed doses (187.5–450 mg), pharmacokinetic modelling confirms optimal dose targeting across body weights.
The efficacy data are striking:
- Median ABR reduction: 81% (range 41–100%) across all VWD types
- Patients switching from prior IV prophylaxis: 75–100% bleed reduction
- Patients with no prior IV prophylaxis: 41–100% bleed reduction
One case presented: One Type 3 patient (50-year-old male, 102.5 kg) had an annualised bleeding rate of 176.5 pre-treatment – including 60 skin cuts, 27 rectal bleeds and refractory GI bleeding despite daily IV infusions.
On VGA039?
ABR dropped to 7 – a 96% reduction – and he was bleed-free for 85 days.
Safety: VGA039 was well tolerated – D-dimer levels remained within normal range across all multi-dose cohorts MD-1 and MD-2, with no signal of prothrombotic risk.
What’s next: All participants have transitioned to the open-label extension.
Phase 3 VIVID 6 (NCT07115004) is now actively enrolling – a global, single-arm crossover study for all VWD types.”
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