Roche announces further data from study of ACE910 in patients with severe haemophilia A

Roche has announced new data from the first study of the novel humanised bispecific antibody ACE910 (RG6013) in people with severe haemophilia A.

The data was presented at the International Society on Thrombosis and Haemostasis (ISTH) annual meeting and is a long-term follow-up of the Phase I study presented at the annual meeting of the American Society of Haematology (ASH) in 2014, which reported data for the first 12 weeks of treatment.

New data from the open-label Phase I extension study suggested that once-weekly subcutaneous administration of ACE910 had a promising prophylactic efficacy profile in people with severe haemophilia A, after a follow-up of 5.6 to 18.5 months. The tolerability profile of ACE910 was consistent with that previously observed in the Phase I study data presented last year. 

People with severe haemophilia A treated with ACE910 experienced fewer bleeding events

“After longer follow-up, the data showed that people with severe haemophilia A who were treated with ACE910 continued to experience fewer bleeding events compared to the six months before they began treatment,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are encouraged by these early data and are moving the ACE910 development programme forward as fast as possible to address the needs of people with haemophilia A. Our goal is to initiate a Phase III trial in patients with factor VIII inhibitors by the end of 2015 and a Phase III trial in patients without inhibitors in 2016.” 

ACE910’s effectiveness irrespective of the presence of factor VIII inhibitors is meaningful because approximately one in every four people with severe haemophilia A develops these inhibitors to factor VIII.  Despite currently available therapies, the formation of inhibitors is one of the major challenges affecting people with severe haemophilia A and there remains a need for effective treatment options for these patients.  

Patients who received ACE910 treatment in the ongoing Phase I study showed a significant reduction in annualised bleeding rate (ABR) after a follow-up of 5.6 to 18.5 months, compared to the rate demonstrated in the 6-month period before study enrolment.