The Food and Drug Administration (FDA) has granted BBT-059 (Bolder Technology) Orphan Drug designation for the treatment of acute radiation syndrome (ARS).

A collection of illnesses fall under the classification of ARS. Death following exposure to high dose radiation typically results from infection or uncontrolled bleeding due to the development of severe neutropenia and thrombocytopenia.

BBT-059 is a long acting interleukin-11 analogue that stimulates the production of platelets. A study of BBT-059 in mice exposed to gamma radiation found that the treatment led to accelerated recovery from radiation-induced peripheral blood neutropenia and thrombocytopenia when administered prior to exposure.

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“These results indicate that BBT‐059 is a promising radiation countermeasure, demonstrating its potential to be used both pre- and postirradiation for hematopoietic acute radiation syndrome with a broad window for medical management in a radiological or nuclear event,” the study authors noted.

Should the treatment be approved, the Orphan Drug designation guarantees the Company 7 years of market exclusivity.

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