Orphan drug status to IL-11 analog for ARSAugust 6, 2019
Bolder BioTechnology, Inc. announced that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the US FDA to treat acute radiation syndrome (ARS).
BBT-059 stimulates production of platelets. It protects against the lethal effects of acute, high dose radiation exposure when administered either prior to or following radiation exposure in animal ARS models. BBT-059 accelerates recovery of multiple blood cell types in irradiated animals.
ARS is a collection of illnesses that occurs following exposure to high doses of ionizing radiation within a short period of time, such as might occur following a nuclear power plant accident or detonation of a nuclear weapon.
Subjects acutely exposed to high dose radiation typically develop severe neutropenia and thrombocytopenia within days to weeks of exposure. Many subjects die during this time period from infections due to a lack of neutrophils or from uncontrolled bleeding due to a lack of platelets.