Imago BioSciences has received approval from the US Food and Drug Administration (FDA) for the company's investigational new drug (IND) application in support of its Phase l/ll clinical trial of IMG-7289 to treat myelofibrosis (MF).
The approval has enabled Imago to begin clinical development of IMG-7289 in the US.
IMG-7289 is a small molecule that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), which is an enzyme regulating gene expression in hematopoietic cells.
The oral inhibitor is currently being investigated in clinical trials by Imago BioSciences.
Imago BioSciences CEO Hugh Young Rienhoff Jr said: “There is a pressing need for novel approaches to the treatment of myeloproliferative disorders including myelofibrosis.”
The Phase l/ll open-label trial aims to evaluate the pharmacodynamics of IMG-7289 in high-risk myelofibrosis patients aged 18 or older.
The trial is also designed to measure changes in spleen volume, patient-reported total symptom scores, mutant allele burden, inflammatory cytokines and bone marrow fibrosis during the treatment period.
Imago started the trial in Australia last year and plans to include various sites in the US this year.
The trial represents the second clinical trial of IMG-7289 sponsored by Imago BioSciences.
The first trial to evaluate IMG-7289 for the treatment of high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) began in 2016. Patient enrolment has yet to be completed.