Imago BioSciences has completed patient enrolment in a Phase I/IIa clinical trial of IMG-7289 for the treatment of high-risk acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS).
A total of 45 patients have been enrolled in the trial, which aims to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-neoplastic activity of IMG-7289.
The trial has already completed its Phase I multiple-ascending dose portion to analyse IMG-7289 as a single agent and has moved towards the Phase IIa expansion arm.
In the Phase IIa arm, Imago BioSciences investigated IMG-7289 in combination with all trans retinoic acid (ATRA) for extended dosing durations.
The company is still treating patients in the final 2a expansion cohort.
Imago BioSciences CEO Hugh Young Rienhoff said: “This study generated a wealth of knowledge about the pharmacokinetics, pharmacodynamics, and safety profile of our LSD1 inhibitor IMG-7289 as a single agent and in combination with ATRA.
“This study provides very clear guidance on how to use IMG-7289 at a variety of doses and in a variety of indications.”
IMG-7289 is a small molecule designed to inhibitslysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and shown to be important in sustaining self-renewal in cancer stem/progenitor cells, particularly neoplastic bone marrow cells.
It is also being evaluated in a second Phase l/lla clinical trial for high-risk myelofibrosis patients aged 18 or older.
The multi-centre, open-label trial is designed to examine the safety, steady-state pharmacokinetics and pharmacodynamics of IMG-7289.
It is currently enrolling patients in the US and Australia.