2 December 2020 - Protagonist Therapeutics today announced that the U.S. FDA has granted fast track designation to PTG-300 in the treatment of polycythemia vera, a rare disease characterised by the excessive production of red blood cells.
PTG-300 is an injectable synthetic peptide mimetic of the natural hormone hepcidin that has demonstrated the ability to dramatically decrease the requirement for phlebotomy in an ongoing Phase 2 study in polycythemia vera patients.
PTG-300 has previously received orphan drug designation for the treatment of polycythemia vera from the U.S. FDA.