American health care company Baxter International (Nasdaq: BAX) has reported positive results from its Phase III trial of the experimental agent BAX 817.
The therapy was trialled in male patients aged 12 to 65 with hemophilia A or B with inhibitors, and met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours. On-demand treatment with BAX 817 had an overall success rate of 92%, and 89% of patients achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
No patient developed binding antibodies or inhibitors to the drug, and no patient discontinued treatment as a result of adverse events, but one subject was hospitalized after a traumatic muscle bleed that did not respond to treatment. Less serious adverse events were deemed consistent with the underlying illness or other aetiologies, and determined to be unrelated to BAX 817.
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