FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009
TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.
True North Therapeutics has announced that the FDA has granted Orphan Drug Designation for the company’s lead product candidate, TNT009 for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia for which there are limited treatment options available for patients.
TNT009 is currently in a Phase Ib clinical study in patients with CAD, and positive interim results from the study were announced in June 2016. True North also received Orphan Drug Designation for TNT009 from the European Medicines Agency (EMA) in February 2016.
“Receiving both US and EMA Orphan Drug Designation for TNT009 is an important milestone in the development of much needed new treatment options for patients with CAD,” said Nancy Stagliano, Chief Executive Officer of True North. “We look forward to continuing development of TNT009 for CAD and reporting additional Phase Ib clinical data when available.”
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