IMG-7289 for Blood Cell Disorders

Overseen By Karin Suarez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Terrence J Bradley, MD

Must not be taking: MAOIs, Romiplostim

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMG-7289, a potential drug for individuals with certain blood disorders, specifically Essential Thrombocythemia (ET) and Polycythemia Vera (PV). The goal is to determine how effectively this treatment controls blood cell counts in patients who haven't responded to standard treatments. Participants must have been diagnosed with ET or PV, struggled with previous treatments, and have high platelet counts. The study involves taking a daily pill and attending regular check-ups to monitor the treatment's effectiveness. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you must stop your current therapy for the condition being studied at least 2 weeks before starting the trial drug (4 weeks for interferon).

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

Research has shown that IMG-7289, also known as bomedemstat, is generally safe and well-tolerated in individuals with blood disorders such as essential thrombocythemia (ET) and myelofibrosis (MF). Studies have found no major safety concerns or severe side effects that would prevent continuation of the treatment. Furthermore, no deaths related to IMG-7289 have been reported in patients with advanced conditions and many genetic mutations. This suggests that the treatment is safe for further testing and use in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for blood cell disorders like essential thrombocythemia (ET) and polycythemia vera (PV) focus on reducing symptoms and controlling blood cell production. However, IMG-7289 is unique because it targets an enzyme called LSD1, which plays a crucial role in regulating blood cell development and proliferation. This innovative mechanism has the potential to more precisely control abnormal blood cell production, which could lead to better outcomes with fewer side effects compared to traditional treatments. Researchers are excited about IMG-7289 because it offers a novel approach that might improve the quality of life for patients with these disorders.

What evidence suggests that IMG-7289 might be an effective treatment for blood cell disorders?

Research has shown that IMG-7289, also known as bomedemstat, offers promising results for treating blood cell disorders like Essential Thrombocythemia (ET) and Polycythemia Vera (PV). In studies with mice, bomedemstat reduced harmful stem cells, decreased bone marrow scarring, and improved overall blood health. Participants in this trial will receive IMG-7289. Patients with these conditions responded well in previous studies, experiencing better control of blood counts and fewer symptoms. This suggests that IMG-7289 could help manage these disorders, especially for those who haven't succeeded with other treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Terrence Bradley, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Adults diagnosed with Essential Thrombocythemia or Polycythemia Vera who haven't responded well to at least one standard treatment. Participants must have certain blood cell counts, agree to contraception, and be able to swallow capsules. Excluded are those with poor physical condition scores, pregnancy/breastfeeding plans, non-US residency, history of splenectomy, unresolved toxicities from past treatments, uncontrolled infections including HIV/hepatitis or bleeding risks.

Inclusion Criteria

I am willing to undergo blood tests, spleen measurements, and bone marrow exams for the study.

I have been diagnosed with Essential Thrombocythemia or Polycythemia Vera.

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

Exclusion Criteria

I do not have any ongoing infections that aren't responding to treatment.

I have a higher risk of bleeding due to blood test results or a history of bleeding disorders.

I am not allergic to IMG-7289, LSD1 inhibitors, or similar drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Pilot Treatment

Initial pilot period where 8 participants receive oral daily dose of IMG-7289 for 24 weeks

24 weeks

Extended Treatment

Second stage group where an additional 16 participants receive IMG-7289 for over 2 years

Over 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• IMG-7289

Trial Overview The trial is testing IMG-7289's ability to control platelet, WBC or RBC levels in patients with ET or PV who've had inadequate responses to previous therapies. It involves regular monitoring through blood draws and bone marrow evaluations.

How Is the Trial Designed?

Group I: IMG-7289 in ET and PV Patients Experimental Treatment 1 Intervention

Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered: * The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity. * The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity.

Who Is Running the Clinical Trial?

Terrence J Bradley, MD

Lead Sponsor

Trials

2

Recruited

20+

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

IMG-7289 in Patients with Essential Thrombocythemia (ET) ... 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7722191/

Novel and combination therapies for polycythemia vera and ... ... trials are currently testing IMG-7289 in ET patients [78]. Telomeres are ... Hydroxyurea in High Risk Polycythemia Vera and Essential Thrombocythemia: Results ...

3. 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 ...

4. onclive.com onclive.com/view/essential-thrombocythemia-and-polycythemia-vera-treatments-are-moving-toward-disease-modification

Essential Thrombocythemia and Polycythemia Vera ... 6 Both agents were found to be effective; however, with longer treatment (> 24 months), PEG was more effective in normalizing blood counts and ...

5. 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 ...

6. 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 a generally safe and well tolerated therapeutic option in patients with MF and ET and has shown clinical activity as a ...

7. umiamihealth.org umiamihealth.org/en/clinical-trials/img7289-in-patients-with-essential-thrombocythemia-et-or-polycythemia-vera-pv

IMG-7289 in Patients With Essential Thrombocythemia (ET) ... 1. Age ≥ 18 years. · 2. Diagnosis of Essential Thrombocythemia or Polycythemia Vera per World Health · 3. Patients that have failed at least one standard therapy ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497121021364

A Phase 2 Study of the LSD1 Inhibitor Img-7289 ... There have been no safety signals, DLTs, or deaths related to drug. In a patient population with advanced disease, a heavy mutation burden and ...

9. 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 ...