On September 19, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed at a European site in its Phase 2b clinical study evaluating IMG-7289 (bomedemstat) for the treatment of myelofibrosis (Press release, Imago BioSciences, SEP 19, 2019, View Source [SID1234551956]).
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The multi-center Phase 2b trial is evaluating the safety, tolerability, and efficacy of IMG-7289. Outcome measures include reduction in spleen volume based on MRI scans and assessment of total symptom scores throughout the study. The trial is an expansion of a Phase 2a safety and dose-range finding study in which IMG-7289 was generally well tolerated in a cohort of 18 patients. Evaluable patients showed a reduction in spleen size with a majority demonstrating a reduction in symptom scores. "Participation of European Investigators in this study takes advantage of the excellence in hematology that resides in Europe as well as their great experience as trialists. Their involvement will help us further advance, on a global scale, this novel agent as a treatment option for patients with myelofibrosis," said Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences. "This study is part of a broader effort in the evaluation of novel treatments for myeloid diseases."
About IMG-7289
U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289, which is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression, myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancy models, including the myeloproliferative neoplasms, which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with checkpoint inhibitor agents in non-clinical models. Additional clinical studies in myeloid diseases are under evaluation.