The Food and Drug Administration (FDA) has granted Fast Track designation to bomedemstat (IMG-7289; Imago BioSciences) for the treatment of essential thrombocythemia, a myeloproliferative disorder characterized by high platelet counts. 

“[Essential thrombocythemia] is a quiet bone marrow cancer that can linger for years,” said Hugh Young Rienhoff, Jr. MD, CEO, Imago Biosciences. “In a subset of patients, the excess of platelets leads to bleeding and clotting including strokes and infarctions, each having a significant impact on these patients.”

Bomedemstat is believed to inhibit lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme that plays an important role in the production and function of megakaryocytes and in self-renewal of malignant hematopoietic stem cells. The investigational agent has been shown to be effective in preclinical studies across a range of myeloid malignancy models. The Company plans to initiate a phase 2 trial to assess bomedemstat in patients with essential thrombocythemia. 

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“With only one FDA approved therapy, one that does not increase overall survival, patients are in desperate need of new options. Based on its mechanism and safety data obtained to date, we believe bomedemstat has the promise to be that new treatment,” added Rienhoff.

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