EMA Grants True North’s TNT009 Orphan Drug Status for Hemolytic Anemia

The European Medicines Agency has awarded orphan drug status to True North Therapeutics’ TNT009 for the treatment of autoimmune hemolytic anemia, including cold agglutinin disease.

CAD is a form of autoimmune hemolytic anemia in which antibodies mistakenly attack red blood cells, causing anemia, fatigue and sometimes fatal thrombosis. TNT009 blocks the classical complement pathway by targeting serine protease within the C1-complex. The compound is in Phase 1b clinical trials in CAD.