Imago BioSciences Presents Positive Data from Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at ASH 2021
- Expanded Phase 2 data set continues to provide compelling rationale for move to registrational clinical program -
- Bomedemstat demonstrated durable clinical improvement in patients with ET who failed at least one standard therapy (usually hydroxyurea) -
- Bomedemstat continues to be generally well-tolerated -
Updated Highlights (as of
- Of the 29 patients treated with bomedemstat for more than 6 weeks:
- 100% (29/29) of patients experienced platelet count reduction to within normal ranges (150 – 400 x 109/L).
- 90% (26/29) of patients achieved a platelet count of less than 400 x 109/L without thromboembolic events, the primary composite endpoint of this study.
- Of the 17 evaluable patients at 24 weeks:
- 71% (12/17) showed a decrease in Total Symptom Score (TSS).
- 53% (9/17) showed a ≥50% decrease in TSS.
- Patients with all genotypes identified in the study (CALR, JAK2V617F, Triple Negative) responded to bomedemstat.
“As of the most recent data cut-off in this Phase 2 trial, bomedemstat as a monotherapy in a 2nd line ET population demonstrated significant and durable hematologic control and symptom improvement while maintaining normal hemoglobin levels. I am delighted with the progress we are making with this study and would like to take this opportunity to thank all of the investigators and patients involved,” said Hugh Young Rienhoff, Jr., M.D., CEO, Imago BioSciences. “Even with only 36 of the up-to 60 patients we plan to enroll, we have commenced planning for a registrational clinical trial for ET. We expect an End-of-Phase 2 meeting and discussion of the Phase 3 Protocol in the second half of 2022.”
Safety & Tolerability
- Bomedemstat was generally well-tolerated.
- The most common AEs (>20%) were dysgeusia (altered taste), constipation, arthralgia, and fatigue.
- 4 patients have discontinued due to AEs.
“We are pleased with the safety and tolerability of Bomedemstat in this trial in a patient population, most of whom were intolerant or resistant to hydroxyurea,” said Wan-
Details on Imago’s ASH Presentation
Oral Presentation Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)
Session: Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK inhibitor Therapies for Myelofibrosis
Date and Time:
For further details, please see the ASH 2021 abstract and presentation on the Imago website here.
About Imago’s Phase 2 Essential Thrombocythemia Program
Essential thrombocythemia (ET) is a rare blood cancer resulting from the overproduction of platelets, which increases the risk of blood clots and bleeding. It is one of the myeloproliferative neoplasms (MPN) family of rare bone marrow diseases, and affects approximately 80,000 – 100,000 patients in the
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
Forward Looking Statements
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These statements may relate to, but are not limited to, the results, conduct, progress and timing of Imago clinical trials, the regulatory approval path for bomedemstat, including a registrational clinical program or review of the Phase 3 Protocol and plans for future operations, as well as assumptions relating to the foregoing. Forward looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Important factors that could affect future results and cause those results to differ materially from those expressed in the forward-looking statements include: our ability to enroll patients in clinical trials, delays in clinical trials or an inability to successfully conduct or complete clinical trials on expected timelines or at all, the occurrence of harmful side effects or other characteristics that indicate bomedemstat does not meet applicable regulatory criteria, changes in the market for bomedemstat that impact its commercial attractiveness, our ability to produce bomedemstat in commercial quantities at an acceptable cost, and other risks related to the regulatory approval path for bomedemstat and our ability to receive regulatory approval for bomedemstat and commercialize bomedemstat. You should not put undue reliance on any forward-looking statements. Forward looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all.
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