Enrollment Begins in Study Evaluating Immune Tolerance Induction with Elocta

Mathew Shanley

Swedish Orphan Biovitrum AB (Sobi) announced this morning that the first patient was enrolled in the open-label, multicenter RelTirate study (NCT03103542) designed to test Elocta (efmoroctocog alfa) in patients with hemophilia A. The trial is a collaborative effort with Bioverativ Therapuetics Inc.

The study is examining the immune tolerance induction (ITI) potential of Elocta in hemophilia A patients who have developed inhibitors that have failed to be resolved with other therapies.

Hemophilia A is characterized by a patient’s inability to properly form blood clots as the result of missing or reduced levels of the Factor VIII protein. The rare genetic disorder leads to patients experiencing recurrent painful bleeding episodes, some of which can be life-threatening. The current standard of care for hemophilia A is replacement therapy, however, some patients develop  antibodies that can make that therapy ineffective.

"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," says Krassimir Mitchev, MD, PhD, Vice President and Medical Therapeutic Area Head of Haemophilia at Sobi in a press release.

The safety and efficacy of Elocta in previously-treated patients have both already been proven in clinical trials and further confirmed in real-world clinical settings. It is a recombinant clotting factor therapy developed using Fc fusion technology to prolong circulation in the body. It is engineered by fusing Factor VIII to the Fc portion of immunoglobulin G subclass 1 (IgG1), enabling Elocta to use an organically occurring pathway to lengthen the time the therapy remains in the body.

The partnership between Sobi and Bioverativ for Elocta includes the former’s final development and commercialization rights in Europe, North Africa, Russia and most Middle Eastern markets. Bioverativ has all manufacturing responsibility and final development and commercialization rights in North America and all other regions in the world.

In November 2015, Elocta was approved in Europe for the treatment of hemophilia A.

Image courtesy of wikimedia commons.

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