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IMG-7289 (bomedemstat) has been granted access to the European Medicines Agency PRIME scheme for the treatment of myelofibrosis

Jul 31, 2020

IMG-7289 (bomedemstat), a lysine-specific demethylase-1 (LSD-1) inhibitor, has been granted access to the PRIME (priority medicines) scheme  of the European Medicines Agency (EMA) for the treatment of myelofibrosis (MF) based on favorable results from the primary analysis of an ongoing phase II study. LSD-1 is an enzyme involved in the maturation of blood cells, and neoplastic stem and progenitor bone marrow cells, and bomedemstat showed improvements in clinical outcomes including symptom scores, spleen volumes, anemia, and bone marrow fibrosis. 1

IMG-7289 (bomedemstat) is currently under investigation in a phase II study ( NCT03136185), which is evaluating safety and tolerability, and pharmacokinetics and pharmacodynamic effects in patients with high or intermediate-2 risk primary and secondary MF who are ineligible for, or have become intolerant or resistant to, a Janus kinase inhibitor. 2It is also currently being evaluated for essential thrombocythemia (ET) and polycythemia vera in a number of studies ( NCT04262141, NCT04081220, NCT04254978), and has been granted orphan drug and fast track designation for the treatment of MF and ET, and orphan drug designation for acute myeloid leukemia by the U.S. Food and Drug Administration (FDA). 1

PRIME is an initiative started by EMA to support the development of medicines that address unmet medical needs. The agency aims to foster an early dialogue with drug developers to accelerate drug development and evaluation. 3

  1. BioSpace. Imago BioSciences granted access by European Medicines Agency to PRIME scheme for IMG-7289 (bomedemstat) in myelofibrosis. https://www.biospace.com/article/releases/imago-biosciences-granted-access-by-european-medicines-agency-to-prime-scheme-for-img-7289-bomedemstat-in-myelofibrosis-/Published Jul 30, 2020. Accessed Jul 31, 2020.
  2. Clinicaltrials.gov. IMG-7289 in patients with myelofibrosis. https://clinicaltrials.gov/ct2/show/NCT03136185. Updated Mar 10, 2020. Accessed Jul 31, 2020.
  3. European Medicines Agency. PRIME: priority medicines. https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines. Accessed Jul 31, 2020.