SAN FRANCISCO, August 22, 2019 – Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289 (bomedemstat) for the treatment of myelofibrosis. IMG-7289 inhibits the enzyme LSD1 (lysine-specific demethylase 1), which is critical for the formation of specific blood cells in the bone marrow that drive myelofibrosis.
“Myelofibrosis remains a major unmet clinical need imposing on patients a great burden of disease. IMG-7289 shows promise to meet this need of relieving patient’s symptoms and improving their quality of life,” said Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences. “Under the Fast Track designation, we seek to expeditiously advance the clinical development of IMG-7289.”
The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need, in an effort to accelerate availability to patients. A therapeutic that receives Fast Track designation can benefit from early and frequent communications with the agency as well as a rolling review of the marketing application.
Ongoing Clinical Study
Imago conducted a Phase 1/2a clinical trial which demonstrated that IMG-7289 was well-tolerated in patients with high or intermediate-2 risk myelofibrosis resistant to or intolerant of approved therapy. In addition, evaluable patients using IMG-7289 showed a reduction in spleen size with a majority demonstrating a reduction in symptom scores. The study was expanded to the ongoing Phase 2b study, recruiting patients in the US, EU and UK, which will utilize a modified dosing schedule that safely optimizes efficacy. For more information visit clinicaltrials.gov (NCT03136185).
IMG-7289 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.
About Imago BioSciences
Imago BioSciences is a clinical-stage, venture-backed pharmaceutical company whose investors include a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron, Greenspring Associates and Xeraya Capital as well as other corporate and venture investors. Imago is focused on improving the management of malignant and life-threatening diseases of the bone marrow. The company is currently focused on the myeloproliferative neoplastic disorders, myelofibrosis, essential thrombocythemia and polycythemia vera. The company is based in California.