IMG-7289 for Essential Thrombocythemia

Overseen By Epp Goodwin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: Hydroxyurea

Must not be taking: MAOIs

Disqualifiers: Pregnancy, HIV, Hepatitis, 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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, IMG-7289, for individuals with essential thrombocythemia, a condition where the body produces too many platelets, raising the risk of blood clots. The trial aims to determine if IMG-7289 can safely and effectively reduce platelet counts in patients who have not responded to or cannot tolerate the usual treatment, hydroxyurea. Suitable candidates have been diagnosed with essential thrombocythemia and require treatment to lower platelet levels, particularly if hydroxyurea has been ineffective or caused adverse side effects. Participants must be able to swallow capsules and will undergo tests such as spleen size checks and blood sampling. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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

Yes, you must stop taking your current Essential Thrombocythemia (ET) therapy at least 2 weeks before starting the study drug, or 4 weeks if you are on interferon.

Is there any evidence suggesting that IMG-7289 is likely to be safe for humans?

Research has shown that IMG-7289 is generally safe for people with essential thrombocythemia. In one study, 24 patients experienced serious side effects, but only 4 of these were linked to the treatment. This indicates that most patients tolerate the treatment well. Additionally, IMG-7289 has improved platelet and white blood cell counts without causing major side effects. While some patients might encounter issues, the overall evidence supports the safety of IMG-7289 for essential thrombocythemia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

IMG-7289 is unique because it works differently from most current treatments for essential thrombocythemia, like hydroxyurea or anagrelide, which primarily focus on reducing platelet production. IMG-7289 targets a specific enzyme called LSD1 (lysine-specific demethylase 1), which plays a role in the regulation of blood cell production. Researchers are excited about this treatment because by targeting LSD1, IMG-7289 may offer a more targeted approach with potentially fewer side effects, improving the quality of life for patients.

What evidence suggests that IMG-7289 might be an effective treatment for essential thrombocythemia?

Research has shown that IMG-7289, also known as bomedemstat, may help treat essential thrombocythemia (ET). Studies have found that this treatment stabilizes blood cell levels in people with ET. Bomedemstat lowers platelet counts and improves symptoms without causing major side effects. It also controls white blood cell levels and reduces genetic changes linked to the condition. Overall, the treatment effectively manages symptoms and improves blood cell levels for those with ET. ^{2 3 4 6 7}

Who Is on the Research Team?

Zohra Nooruddin, MD

Principal Investigator

Mays Cancer Center

Are You a Good Fit for This Trial?

Adults diagnosed with Essential Thrombocythemia who have high platelet counts despite hydroxyurea treatment, can swallow capsules, and will use contraception. Excluded are those with unresolved toxicities from past treatments, active infections including HIV/hepatitis, bleeding risks, pregnancy/breastfeeding plans within six months or current breastfeeding.

Inclusion Criteria

I can swallow pills.

Peripheral blast count <10% pre-dose Day 1

I agree not to father a child or donate sperm for a month after my last dose.

Exclusion Criteria

I need considerable assistance and am unable to carry out any work activities.

I have had more than 3 blood transfusions in the last 6 months or any transfusion in the last 4 weeks.

You have signs that show you might have a higher chance of bleeding, such as:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMG-7289 orally once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IMG-7289

Trial Overview The trial is testing the oral drug IMG-7289 for patients with Essential Thrombocythemia. It's an open-label study where all participants know they're receiving the medication to see how it affects their condition.

How Is the Trial Designed?

Group I: IMG-7289 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Imago BioSciences,Inc.

Industry Sponsor

Trials

10

Recruited

380+

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

Industry Sponsor

Trials

10

Recruited

380+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04262141

Study Details | NCT04262141 | IMG-7289 in Patients with ... The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000649712305351X

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.

3. mpn-hub.com mpn-hub.com/medical-information/updates-of-img-7289-bomedemstat-in-treating-myelofibrosis-and-essential-thrombocythemia

Updates of IMG-7289 (bomedemstat) in treating ... IMG-7289 (bomedemstat) is an orally active LSD1 inhibitor which is known to have favorable impact on myelofibrosis (MF) symptoms. Recently, Gill ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9429289/

A PHASE 2 STUDY OF THE LSD1 INHIBITOR IMG-7289 ... Bomedemstat is generally well-tolerated, reduces platelets, improves symptoms, reduces the mutation burden, and moderates WBC counts without affecting ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04254978

NCT04254978 | Study of Bomedemstat in Participants With ... This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential ...

6. 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 ... Twenty-four patients reported serious AEs (SAE), with related events ( per PI) in 4 patients.

7. mpnresearchfoundation.org mpnresearchfoundation.org/imago-biosciences-granted-fast-track-designation-for-img-7289-in-essential-thrombocythemia/

IMAGO BIOSCIENCES GRANTED FAST TRACK ... The US Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289 (bomedemstat) for the treatment of Essential ...