Inspiration reports Accur8 Phase 2/3 study positive interim data

9th July 2012 (Last Updated July 9th, 2012 18:30)

Inspiration Biopharmaceuticals has reported positive interim data from its ongoing prospective, open- label Accur8 Phase 2 / 3 study, designed to demonstrate the efficacy of OBI-1 as a treatment for serious bleeds in individuals aged 18 and older with acquired haemophilia A.

Inspiration Biopharmaceuticals has reported positive interim data from its ongoing prospective, open- label Accur8 Phase 2 / 3 study, designed to demonstrate the efficacy of OBI-1 as a treatment for serious bleeds in individuals aged 18 and older with acquired haemophilia A.

OBI-1, an investigational recombinant porcine factor VIII (FVIII), is designed to avoid recognition by antibodies to human FVIII, as the antibodies would otherwise attack any human form of FVIII and cause a life-threatening bleeding disorder.

People with inhibitors to human FVIII may respond to porcine FVIII, replacing the missing step in their coagulation cascade, according to the company.

Seven out of seven trial participants with severe bleeds that were not controlled with bypassing agents and who were enrolled and treated with OBI-1, experienced control and subsequent resolution of their bleeds, according to the interim analysis.

"Seven out of seven trial participants with severe bleeds experienced control and subsequent resolution of their bleeds."

Children's Hospital Los Angeles clinical research and clinical investigation centre haematologist and director, Edward Gomperts, said: "These preliminary findings are encouraging and suggest that further investigation of the efficacy and safety of OBI-1 in this population is warranted."

To further assess OBI-1's ability to control bleeding in people with congenital haemophilia A with inhibitors, a prospective, open-label second Accur8 Phase 2 / 3 clinical trial is currently underway.

The company is also evaluating its recombinant factor IX therapy for the prevention and treatment of bleeding in people with haemophilia B.

Inspiration Biopharmaceuticals CEO, John P Butler, said that the company is growing its presence and involvement at the world federation of haemophilia annual congress, the premier global scientific gathering for the haemophilia community.

"This meeting gives us an opportunity to connect face-to-face with leaders in the global haemophilia community, discuss their ongoing needs and determine the role Inspiration can play in improving the lives of people with haemophilia around the world," Butler added.