On October 1, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed in the first Imago-sponsored Phase 2b clinical trial of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET) (Press release, Imago BioSciences, OCT 1, 2020, View Source [SID1234567853]).
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"We are excited to start this study. There are many patients with essential thrombocythemia in need of alternatives to the current standards of care. Bomedemstat has the potential to serve as a new option for such patients," said Hugh Young Rienhoff, Jr. MD, CEO, Imago BioSciences.
This Phase 2b multi-center, open-label study is designed to assess the safety, efficacy, and pharmacodynamics of bomedemstat, an oral inhibitor of the epigenetic enzyme lysine-specific demethylase 1 (LSD1) (www.clinicaltrials.gov Identifier NCT04254978). Eligible patients aged 18 or older with ET who have failed at least one standard therapy and require treatment in order to lower their platelet count will be considered for participation in this study. Exploratory assessments include the serial measurement of mutant allele frequencies and changing plasma cytokine profiles. The trial is being conducted in the United States, the United Kingdom, Europe, New Zealand, and Australia.
About Bomedemstat (IMG-7289)
In addition to the ET study, bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Preliminary results have been presented at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).
Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141 and NCT04081220). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.