On June 11, 2021 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported updates on two Phase 2 clinical trials of bomedemstat, one in patients with essential thrombocythemia (ET) and, the second in patients with advanced myelofibrosis (MF) (Press release, Imago BioSciences, JUN 11, 2021, View Source [SID1234583909]). The data were presented in two e-poster presentations during the 26th European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress (EHA 2021), taking place June 9-17, 2021.
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Poster title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) in Patients with Essential Thrombocythemia
The presented data show that bomedemstat was generally well-tolerated by patients with ET and demonstrated encouraging clinical activity as a monotherapy, showing symptomatic improvement in patients with significant MPN symptoms. Of the 12 patients dosed with bomedemstat for more than six weeks, 83% displayed substantial improvements in platelet count reduction, achieving platelets ≤ 400×109/L. Of the 10 patients entering the study with elevated white blood cell counts and evaluable at 12 weeks, 80% saw these counts fall within normal ranges. These improvements were achieved while maintaining stable hemoglobin levels. There were no dose limiting toxicities, no safety signals per Safety Advisory Board and one serious adverse event that was deemed unrelated.
"These encouraging data show that bomedemstat was well-tolerated and has the potential to bring meaningful clinical benefits for patients with essential thrombocythemia," said Wan-Jen Hong, M.D., chief medical officer of Imago BioSciences. "We are excited about these preliminary results from our lead asset, and look forward to completing enrollment of this study in order to lay the groundwork for a planned pivotal study in essential thrombocythemia."
Poster title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) in Patients with Advanced Myelofibrosis
The presented data from an ongoing Phase 2 study indicated that bomedemstat as a monotherapy for patients with advanced MF offered a distinct clinical benefit profile, and was generally well-tolerated among participants. Of the 16 patients evaluable at 24 weeks, 94% showed improvements in total symptom scores (TSS), with a reduction of 50% or greater in almost a third of this subset. In an analysis of 34 patients evaluated for mutant allele frequencies (MAFs), MAFs decreased in 44% of patients and were stable in 47%, with no new mutations in up to 660 days of follow-up. Of the 18 patients evaluable for splenomegaly at 24 weeks, 89% had a reduction in spleen volume, with that of one patient decreasing by more than 35%. There were no dose limiting toxicities, no safety signals per Safety Advisory Board, and no progression to acute myeloid leukemia (AML).
"These updated clinical results reveal that bomedemstat continues to offer distinct clinical benefits for patients with advanced MF, showing overall improvement in total symptom scores, spleen volumes and anemia," said Wan-Jen Hong, M.D., chief medical officer of Imago BioSciences. "The study is now fully enrolled, so we look forward to sharing our cumulative data as we continue to advance this investigational program for patients who have few therapeutic alternatives."
Poster presentations are available on the EHA (Free EHA Whitepaper) Virtual Congress platform. The posters will also be available on the Imago website here.