Roche has reported promising Phase 1/2 trial results for NXT007, a next-generation bispecific antibody designed for the treatment of people with haemophilia A.
Developed by Chugai, part of the Roche Group, NXT007 enables haemostatic normalisation in patients without factor VIII inhibitors, offering a new preventive treatment option.
The investigational drug builds on Hemlibra’s framework, optimising factor VIII-mimetic activity and half-life to enhance potency, efficacy, and dosing convenience.
NXT007 combines factor IXa and factor X to activate the natural coagulation cascade, aiming for sustained bleed protection and reduced treatment burden.
Roche’s chief medical officer and global product development head Levi Garraway said: “These NXT007 data are promising for people with haemophilia A and underscore our ongoing commitment to advancing care and addressing the real-world challenges faced by this community.
“Hemlibra established a new standard of care, and our focus is to continue to deliver breakthrough innovation that might ultimately help people with haemophilia to live their lives in a manner unaffected by this condition.”
The NXTAGE study’s early data suggest NXT007’s potential for haemostatic normalisation, with a tolerable safety profile and no thromboembolic events reported.
The drug is being evaluated in a comprehensive clinical development programme, including ongoing Phase 1/2 trials and anticipated Phase 2 data later this year.
Roche plans three Phase 3 studies for 2026, including a head-to-head comparison with Hemlibra, the first subcutaneous prophylactic treatment with flexible dosing options.
Part B of the NXTAGE study, conducted in Japan, South Korea, and Taiwan, involves 30 participants aged 12 to 65, receiving ascending doses of NXT007 every two to four weeks.
The primary analysis showed no treated bleeds in the highest dose cohorts, with NXT007 well tolerated and no thromboembolic events observed.
Recently, Roche has announced a CNY2.04bn ($283m) investment in building a new biopharmaceutical manufacturing facility in Shanghai’s Pudong New Area.
The new biologics manufacturing facility will be built in Zhangjiang High-tech Park, as part of Roche’s strategy to enhance its localisation efforts in the Chinese market.
