FDA concedes IND for Imago BioScience’s IMG-7289 in the U.S
Clinical-stage pharmaceutical company, Imago BioSciences developing novel therapies for hematological and inflammatory diseases asserted FDA‘s acceptance of their Investigational New Drug application giving their nod for the Clinical development of IMG-7289 in the U.S.
Hugh Young Rienhoff, Jr. M.D., Imago’s Chief Executive Officer said “There is a pressing need for novel approaches to the treatment of myeloproliferative disorders including myelofibrosis.”
The Phase 1/2 open-label clinical trial is implied to assess the pharmacodynamics of IMG-7289, an an oral inhibitor of the epigenetic enzyme lysine-specific demethylase 1 (LSD1) in high-risk myelofibrosis patients aged 18 or older. Assessments include measuring changes in spleen volume, patient reported total symptom scores, mutant allele burden, inflammatory cytokines and bone marrow fibrosis over the course of the treatment period.
IMG-7289, an investigational agent currently being evaluated in ongoing clinical trials, is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating gene expression in hematopoietic cells. In non-clinical models, the inhibition of LSD1 has been shown to limit self-renewal in neoplastic stem cells such as those in acute myeloid leukemia and myelofibrosis.