Roche | MEDIA
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Early data suggest Roche’s NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Roche announced positive phase I/II data for NXT007, a next-generation bispecific antibody for haemophilia A, at the 2025 ISTH Congress. The data showed no treated bleeds in the highest dose groups and a tolerable safety profile, prompting progression to phase III trials. NXT007 aims to normalize haemostasis and minimize treatment burden, building upon the success of Hemlibra. Three phase III studies are planned for 2026, including a head-to-head comparison with Hemlibra. The NXTAGE study involved 30 participants receiving varying doses of subcutaneous NXT007. NXT007's mechanism involves bringing together factor IXa and factor X, crucial for blood clot formation. Roche's extensive experience in haematology underpins the development of NXT007. The company aims to provide a broader therapeutic choice for haemophilia A patients. Haemophilia A is a serious inherited bleeding disorder affecting approximately 900,000 people globally.