Bolder BioTechnology Announces FDA Orphan Drug Designation for BBT-059

Bolder BioTechnology announced its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug Administration for treatment of Acute Radiation Syndrome (ARS). Orphan Drug designation is reserved for drugs that treat diseases with fewer than 200,000 patients in the United States. Orphan drug designation provides seven years of market exclusivity for the drug, tax incentives for clinical trial development, waiver of Biologics License Application fees, and a closer working relationship with the Food and Drug Administration.

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 (low numbers of neutrophils) and thrombocytopenia (low numbers of platelets) 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.

BBT-059 is a proprietary, long-acting interleukin-11 analog that stimulates production of platelets, a type of blood cell important for blood clotting. BBT-059 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 (platelets, red blood cells, neutrophils) in irradiated animals.

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