Pharmaceutical company Chrysalis BioTherapeutics Inc reported on Wednesday the receipt of the Orphan Drug Designation (ODD) for its lead compound TP508 (rusalatide acetate) for the treatment of acute radiation syndrome (ARS), from the US Food and Drug Administration (FDA) Office of Orphan Product Development and the European Medicines Agency (EMA).
Following exposure to high levels of nuclear radiation, individuals develop ARS or radiation sickness affecting multiple organ systems and often leading to death within days, weeks, or months of exposure.
TP508 is a regenerative peptide drug representing a natural part of human thrombin that is released upon tissue injury to initiate healing.
The compound has demonstrated safety and potential efficacy in non-clinical and in human clinical tissue repair trials, Chrysalis BioTherapeutics said.
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