Roche candidate shows early promise for treating haemophilia A
Ella Day | June 25, 2025 | News story | Research and Development | Chugai, Haematology, Roche, clinical trial, haemophilia a, prophylactic therapy
Roche has announced encouraging early results from its phase 1/2 trial of NXT007, an investigational bispecific antibody for haemophilia A. Data presented at the 2025 International Society on Thrombosis and Haemostasis Congress on 21 to 25 June, Washington DC, US, indicates that NXT007 may offer haemostatic normalisation in patients (without factor VIII inhibitors).
NXT007, developed by Roche subsidiary Chugai, a Japanese biopharma, is designed to enhance clotting by mimicking factor VIII activity and is administered subcutaneously. In the NXTAGE study, patients in the highest dose cohorts experienced no treated bleeds, and the therapy demonstrated a favourable safety profile, with no thromboembolic events reported.
“This NXT007 data is promising for people with haemophilia A and underscores our ongoing commitment to advancing care,” said Levi Garraway, Roche’s chief medical officer. “We aim to deliver innovations that might ultimately help patients live unaffected by this condition.”
The study enrolled 30 individuals aged 12 to 65 years across Japan, Taiwan and South Korea. Participants received ascending doses of the candidate every two to four weeks following a short loading period.
The positive findings support the launch of three phase 3 trials in 2026, including a study against Roche’s approved therapy, Hemlibra (emicizumab).
Roche’s ambition is to reduce treatment burden and elevate bleed protection. NXT007 is intended to provide a convenient, long-acting prophylactic therapy, offering patients greater freedom from frequent monitoring and treatment adjustments. Further phase 2 data is expected later this year.
Ella Day
25/6/25
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