First Patient Enrolled in ITI Trial Using Eloctate
Swedish Orphan Biovitrum (Sobi) recently announced the successful enrollment of the first hemophilia A patient in the company’s ReITIrate clinical trial. The phase 4 study, which is being sponsored by Sobi and Bioverativ Therapeutics, is designed to evaluate the use Eloctate™ for immune tolerance induction (ITI) therapy in hemophilia A patient with inhibitors. ITI is an effective approach to inhibitor eradication in which the body begins to tolerate a therapy after daily doses of factor are administered over time.
Eloctate™ is a recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy designed to keep the infused clotting factor circulating in the body longer, stretching the time between infusions. The therapy first received approval from the U.S. Food and Drug Administration in 2014 for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A (factor VIII deficiency).
ReITIrate investigators are currently recruiting participants who have developed inhibitors and who have been previously unresponsive to other therapies. They will investigate the ability of Eloctate™ to help patients with hemophilia A inhibitors achieve successful ITI.
Enrolled participants will be treated with Eloctate™ at 200 international units (IU) administered once daily or in several injections throughout the day. The study will continue for a maximum of 60 weeks. As per trial design, participants who meet the criteria for ITI success will receive tapered doses over 16 weeks until a prophylactic dose is achieved as defined by the investigator. Participants will subsequently be followed for 32 weeks while receiving prophylactic treatment with Eloctate™. The estimated completion date for the study is April 2020.
“We are committed to provide treatment options to patients with hemophilia that will enable them to make choices and live the lives they would like to live. The ReITIrate study is very much aligned with that commitment and may address one of the most critical questions – treatment management of patients who have developed inhibitors,” said Krassimir Mitchev, MD, PhD, Vice President and Medical Therapeutic Area Head of Haemophilia at Sobi.
Source: Hemophilia New Today, November 13, 2017