Wolfgang Miesbach/LinkedIn
Jul 21, 2026, 19:41
Wolfgang Miesbach: SR604 Restores Thrombin Generation Where It Is Needed
Wolfgang Miesbach, Professor of Medicine at Frankfurt University Hospital, shared a post on LinkedIn:
“New haemophilia treatment restoring thrombin generation where it is needed – with signals of lower inflammation.
Late-breaking at ISTH 2026 in Paris: the Phase IIb read-out for SR604, a subcutaneous anti-APC antibody dosed as infrequently as every 8 weeks.
Having posted on the biology yesterday, here are the study results:
- Design – open-label, multicentre; 0.4 mg/kg SC randomised to Q4W, Q6W, or Q8W; 24-week observation with a 24-week extension.
- Patients – 36 treated (28 haemophilia A, 8 B), with and without inhibitors.
- Efficacy – ABR fell approximately 91% in the Q4W cohort (from 37.3 to 3.3; 1.8 in weeks 12–24) and approximately 77% with Q8W. Roughly 90% APC inhibition was sustained across the interval – the pharmacodynamic basis for such infrequent dosing.
- Safety – no thrombotic events, no treatment-related adverse events, no injection-site reactions. Fibrinogen, D-dimer and FDP stayed flat, i.e. no laboratory signal of systemic hypercoagulability. Immunogenicity was low.
- Exploratory – reductions in TNF-α and a modest HJHS improvement (from 27.7 to 24.9), supporting further evaluation of potential anti-inflammatory, joint-protective effects.
By acting on locally generated APC at sites of coagulation activation, SR604 restores balance where and when it is needed, rather than suppressing anticoagulation systemically.
Congratulations to the authors – Lijun Xia, Renchi Yang, Feng Xue and co-authors.”
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