- Interim Data Update at European Hematology Association (EHA) meeting in June and Results from Completed Phase 2 Study Expected in Second Half of 2022
- End-of-Phase 2 Meeting with U.S. Food and Drug Administration (FDA) Expected in Second Half of 2022
SOUTH SAN FRANCISCO, Calif., May 03, 2022 (GLOBE NEWSWIRE) — Imago BioSciences, Inc. (“Imago”) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that enrollment has been completed for the Phase 2 clinical study of bomedemstat for the treatment of essential thrombocythemia (ET) with 73 patients enrolled, exceeding the initial target enrollment of 60 patients. This study is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat, an oral lysine-specific demethylase 1 (LSD1) inhibitor, in patients with ET who have failed at least one standard therapy.
“We are pleased to have completed enrollment in our global Phase 2 clinical study of bomedemstat for the treatment of patients with ET and gratified to have exceeded our initial enrollment target. This is an important milestone taking us one step further in the development of a novel treatment for patients with ET who lack adequate treatment options,” said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago. “I thank the patients who enrolled in the trial, the clinical investigators and Imago team who worked tirelessly to advance the study to this point. We will present interim data from this study at the June EHA meeting and results from the completed study later this year. We are also planning for an end-of-Phase 2 meeting with the FDA in the second half of 2022 to lay the groundwork for a Phase 3 registrational study.”
In December 2021, Imago presented a positive data update at the 2021 American Society of Hematology (ASH) Annual Meeting and Exposition from the Phase 2 ET clinical study. As a monotherapy in a 2nd line ET population, bomedemstat demonstrated significant and durable hematologic control and symptom improvement while maintaining hemoglobin levels. The data demonstrated that 93% of patients dosed for more than 6 weeks with bomedemstat achieved a reduced platelet count to within the normal range, a primary clinical objective. Based on the ASH data, bomedemstat continued to be generally well-tolerated and demonstrated an encouraging safety profile in ET patients.
Original press release here.
