Researchers from the Institute Krems Bioanalytics at IMC Krems University of Applied Sciences have co-authored a scientific poster presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress, held from 11 to 15 July 2026 in Paris, France. Monika Gretić contributed to the study as co-author.
The poster reports the final results of a phase 3, prospective, open-label study (NCT02615691). The study investigated previously untreated patients with severe haemophilia A who were treated with rurioctocog alfa pegol. It was funded by Takeda Development Center Americas, Inc., for which the Institute acts as a contract research laboratory.
The Institute Krems Bioanalytics developed and validated the ELISA-based bioanalytical assays used to detect IgM and IgG binding antibodies to factor VIII (FVIII), polyethylene glycol (PEG) and PEG-FVIII. The assays followed a two-step screening and confirmatory approach, in line with regulatory guidelines. The team also acknowledges the contribution of Peter Allacher to the development and validation of these assays.
In total, 146 participants were enrolled from 55 sites in 19 countries, of whom 120 received at least one dose. Eleven participants developed FVIII inhibitors, corresponding to an inhibitor rate of 0.11. Among the 92 participants without inhibitors who had at least 100 exposure days, 50 tested positive for binding antibodies; persistent and transient PEG-FVIII IgG antibodies were detected most frequently. Overall, the FVIII inhibitor rate remained low.
If you would like to discuss how the Institute Krems Bioanalytics can support your preclinical or clinical development programme, we would be glad to hear from you.
