True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD

Top-line Phase Ib data in patients with CAD expected in mid-2016.

“Receiving Orphan Drug Designation from the EMA is another important step forward for True North as we continue to advance development of TNT009,” said Nancy Stagliano, Chief Executive Officer of True North. “We recently initiated a Phase Ib clinical study evaluating TNT009 in patients with CAD and look forward to reporting top-line data later this year.”

TNT009 is a first-in-class monoclonal antibody that selectively inhibits the Classical Complement pathway by targeting C1s, a serine protease within the C1-complex in the Complement pathway of the immune system. TNT009 thereby prevents downstream disease processes involving phagocytosis, inflammation, and cell lysis. With a unique mechanism of action and high target specificity, TNT009 selectively inhibits disease processes in the Classical Complement pathway while maintaining the important immune surveillance provided by the Alternative Complement Pathway and Lectin Complement Pathway. TNT009 is currently in clinical development for the treatment of Cold Agglutinin Disease (CAD), a rare disease in hematology. TNT009 is also being evaluated in three other complement-mediated rare diseases that share the same basic underlying mechanism in the hematology, transplant and dermatology settings.