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news.Baxter International has reported positive results from its Phase III clinical trial of BAX 817, an investigational recombinant factor VIIa (rFVIIa), designed to treat people with hemophilia A or B who develop inhibitors.
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The trial was designed to evaluate the safety and efficacy of BAX 817 in male patients aged 12 to 65 years with hemophilia A or B with inhibitors over a six-month period using on-demand therapy.
The prospective, open-label, randomized, multicenter trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both treatment regimens, dosing either 3×90 µg/kg or 1×270 µg/kg, with an overall success rate of 92%.
The company said that further 89% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
Baxter BioScience vice president and global head of research and development John Orloff said: "The development of inhibitors remains one of the most significant challenges in treating hemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes.
"These positive results reflect our commitment to addressing the complex treatment of hemophilia patients with inhibitors, and reinforce our legacy of advancing hemophilia care worldwide."
Baxter said that none of the patients developed inhibitors or binding antibodies to BAX 817, and none discontinued treatment due to an adverse event (AE).
Complete data from the trial, which will include additional efficacy and safety outcomes, will be reported at a medical meeting held later this year.
If approved, BAX 817 would strengthen the company’s existing portfolio of hemophilia and inhibitor treatments within its biopharmaceutical business, including FEIBA and the recently approved OBIZUR for acquired hemophilia A.
According to the company, infusion of FEIBA should not exceed a dose of 100 units per kg body weight every six hours and daily doses of 200 units per kg body weight.
Image: Baxter’s Phase III trial will evaluate the safety and efficacy of BAX 817 in male patients aged 12 to 65 years with hemophilia A or B with inhibitors. Photo: courtesy of Baitong333/ freedigitalphotos.net