Jan 12, 2020: Imago BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET), a bone marrow disease linked with high platelet counts and potentially catastrophic vascular complications.
Bomedemstat inhibits the enzyme LSD1 (lysine-specific demethylase 1), as a result preventing excess platelet and neutrophil production.
The FDA grants Fast Track designation in order to facilitate development and expedite the review of therapies with the potential to treat a severe condition where there is an unmet medical need.
A therapeutic that receives Fast Track designation can benefit from the early and frequent communication with agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more speedily.
Bomedemstat is a small molecule that was discovered by Imago BioSciences, inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme essential for the production and normal function of megakaryocytes and for self-renewal of the malignant hematopoietic stem or progenitor cells.
Megakaryocytes are the primary producer of the platelets and cytokines that drive essential thrombocythemia pathogenesis.