Bomedemstat for Myeloproliferative Disorders

No longer recruiting at 19 trial locations

Overseen By Jennifer Peppe

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Imago BioSciences,Inc.

Must not be taking: Romiplostim

Disqualifiers: Pregnancy, Breastfeeding, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of bomedemstat (an LSD1 inhibitor) for individuals with myeloproliferative neoplasms, a blood disorder where the bone marrow produces too many blood cells. Participants will take bomedemstat as a daily pill to determine if it continues to manage their condition effectively. It suits those who participated in a previous bomedemstat study and are benefiting from the treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications, as the trial excludes participants using prohibited medications like romiplostim. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that bomedemstat is likely to be safe for humans?

Research has shown that bomedemstat is generally safe for patients. In one study, many participants took bomedemstat without issues and experienced benefits. Early reports indicated it helped control blood cell levels in people with essential thrombocythemia (ET), a type of blood disorder. Another study found that combining bomedemstat with ruxolitinib improved symptoms without causing major side effects. These findings suggest that bomedemstat is safe for many people, though individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Bomedemstat is unique because it targets an enzyme called LSD1, which plays a crucial role in the growth of abnormal blood cells in myeloproliferative disorders. Unlike the standard treatments like hydroxyurea or interferon, which mainly focus on controlling blood counts and symptoms, bomedemstat offers a novel approach by directly interfering with the disease's underlying mechanisms. Researchers are excited because this targeted action could lead to more effective management of the disease with potentially fewer side effects.

What evidence suggests that bomedemstat might be an effective treatment for myeloproliferative disorders?

Research has shown that bomedemstat, the treatment under study in this trial, may help treat certain blood disorders. In studies, patients taking bomedemstat experienced improvements in symptoms such as an enlarged spleen. In mouse models of these disorders, bomedemstat reduced harmful stem cells and lowered inflammation, also aiding with bone marrow problems. These findings suggest bomedemstat could be a promising option for people with specific blood conditions. ^{4 5 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for patients with myeloproliferative disorders who have already completed a treatment period in a previous bomedemstat study. They must be assessed by the investigator as suitable for continued dosing and agree to use contraception. Excluded are those on certain medications, unable to consent or comply, pregnant or breastfeeding women, participants in other trials, and anyone non-compliant in past studies.

Inclusion Criteria

Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201)

In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat

Exclusion Criteria

I agree to use birth control from enrollment until 14 days after my last dose.

I am not pregnant, breastfeeding, nor planning to during the study.

Ongoing participation in another investigational study (except observational studies)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

Open-label extension

Participants continue to receive bomedemstat to assess long-term safety and efficacy

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bomedemstat

Trial Overview

The trial tests the long-term safety and effectiveness of an oral drug called bomedemstat (MK-3543) for people with blood disorders like primary myelofibrosis and essential thrombocythemia. It's an extension study for those who've been part of prior related research.

How Is the Trial Designed?

Group I: Bomedemstat Experimental Treatment 1 Intervention

All participants will receive bomedemstat via oral capsule daily for 169 days with additional treatment continuing in patients deriving clinical benefit.

Who Is Running the Clinical Trial?

Imago BioSciences,Inc.

Lead Sponsor

Trials

10

Recruited

380+

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Lead Sponsor

Trials

10

Recruited

380+

Published Research Related to This Trial

The discovery of the JAK2V617F mutation has led to significant advancements in the treatment of myeloproliferative neoplasms (MPN), particularly with the development of JAK inhibitors like Ruxolitinib, which has shown effectiveness in reducing spleen size and improving quality of life in patients with myelofibrosis (MF).

In addition to JAK inhibitors, other innovative treatments such as immunomodulatory drugs (like pomalidomide), kinase inhibitors, and HDAC inhibitors are being explored in clinical trials, suggesting a promising future for combination therapies in MPN management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Novel therapeutic options in the treatment of BCR/ABL-negative myeloproliferative neoplasms]. Döhner, K., Stegelmann, F., Schlenk, RF., et al.[2021]

In a study involving 39 lower risk MDS patients, the thrombopoietin mimetic romiplostim reduced the incidence of clinically significant thrombocytopenic events (CSTEs) compared to placebo, suggesting it may help manage lenalidomide-induced thrombocytopenia.

Patients receiving romiplostim had fewer dose reductions or delays in lenalidomide treatment due to low platelet counts, indicating that romiplostim could improve the tolerability of lenalidomide therapy in MDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 study evaluating the efficacy and safety of romiplostim treatment of patients with low or intermediate-1 risk myelodysplastic syndrome receiving lenalidomide. Wang, ES., Lyons, RM., Larson, RA., et al.[2021]

In a study of 40 patients with low- or intermediate-risk myelodysplastic syndromes (MDS) receiving azacitidine, romiplostim showed a lower incidence of clinically significant thrombocytopenic events compared to placebo, with rates of 62% and 85%, respectively.

Romiplostim at a dose of 750 μg significantly increased median platelet counts during treatment, indicating potential clinical benefits for MDS patients, although the differences in thrombocytopenic events were not statistically significant due to small sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 study of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. Kantarjian, HM., Giles, FJ., Greenberg, PL., et al.[2021]

TG101348, a selective JAK2 inhibitor, demonstrated significant therapeutic effects in a mouse model of myeloproliferative disease caused by the JAK2V617F mutation, including reduced hematocrit and leukocyte counts.

The treatment showed no apparent toxicities and did not affect T cell numbers, indicating a favorable safety profile while effectively targeting the disease at the molecular level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of TG101348, a selective JAK2 inhibitor, in treatment of a murine model of JAK2V617F-induced polycythemia vera. Wernig, G., Kharas, MG., Okabe, R., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05223920?term=NCT05223920&rank=1

An Extension Study of Bomedemstat (IMG-7289/MK-3543) ...

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants ...

2.

ashpublications.org

ashpublications.org/blood/article/142/Supplement%201/621/499277/Phase-2-Study-to-Assess-the-Safety-and-Efficacy-of

Phase 2 Study to Assess the Safety and Efficacy of ...

These early results suggest that the addition of bomedemstat to a ruxolitinib regimen is well tolerated, improves splenomegaly and symptom scores, and ...

3.

merck.com

merck.com/news/merck-announces-phase-3-trial-initiation-for-bomedemstat-an-investigational-candidate-for-the-treatment-of-certain-patients-with-essential-thrombocythemia/

Merck Announces Phase 3 Trial Initiation for Bomedemstat, ...

Bomedemstat has U.S. Food and Drug Administration Orphan Drug and Fast Track Designations for the treatment of ET and myelofibrosis (MF), Orphan ...

4.

horizonscandb.pcori.org

horizonscandb.pcori.org/report/topics/549

Bomedemstat (IMG-7289) to treat myelofibrosis

Bomedemstat (IMG-7289) is an oral medication under study to treat myelofibrosis, a myeloproliferative neoplasm (ie, disorder) in which bone marrow stem cells ...

5.

mpn-hub.com

mpn-hub.com/medical-information/results-from-an-ongoing-phase-ii-study-of-img-7289-bomedemstat-in-patients-with-advanced-mf

Results from an ongoing phase II study of IMG-7289 ...

In MPN mouse models, bomedemstat has shown to deplete malignant stem cells, decrease bone marrow fibrosis, reduce cytokine release, and improve ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05223920

An Extension Study of Bomedemstat (IMG-7289/MK-3543) ...

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants ...

7.

ashpublications.org

ashpublications.org/blood/article/142/Supplement%201/747/502285/Bomedemstat-IMG-7289-an-LSD1-Inhibitor-Manages-the

Bomedemstat (IMG-7289), an LSD1 Inhibitor, Manages the ...

This study demonstrates that treatment with bomedemstat results in a consistent hematologic response in the majority of patients with ET.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06351631

NCT06351631 | A Study to Evaluate Safety and Efficacy of ...

The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have ...