Research & Development
Bolder BioTechnology wins FDA's ODD for BBT-059 for treating ARS
13 June 2019 -

Human protein company Bolder BioTechnology Inc reported on Wednesday the receipt of orphan drug designation (ODD) from the US Food and Drug Administration for BBT-059 for the treatment of Acute Radiation Syndrome (ARS).

ARS is a collection of illnesses that occurs following exposure to high doses of ionising radiation within a short period of time. Subjects acutely exposed to high-dose radiation typically develop low numbers of neutrophils and low numbers of platelets within days of exposure and many die during this time period from infections.

According to the company, BBT-059 is a proprietary, long-acting interleukin-11 analog that stimulates production of platelets, a type of blood cell important for blood clotting. 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. It accelerates recovery of multiple blood cell types (platelets, red blood cells, neutrophils) in irradiated animals.

Orphan drug designation provides seven years of market exclusivity for the drug, tax incentives for clinical trial development, waiver of Biologics License Application fees as well as a closer working relationship with the US FDA.

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