Bomedemstat for Polycythemia Vera

No longer recruiting at 20 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Disqualifiers: HIV, Hepatitis B/C, Bleeding disorders, 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: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called bomedemstat for individuals with polycythemia vera, a condition where the body produces too many red blood cells, potentially leading to blood clots and other issues. The trial aims to assess the safety and effectiveness of bomedemstat, as well as how the body processes and responds to it. Participants who experience improvement and tolerate the treatment well may continue taking it for an extended period. Those who have tried other treatments without success and have mild bone marrow changes might be suitable candidates for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prior cytoreductive therapy for at least 2 weeks (4 weeks for interferon) before starting the study drug.

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

Research has shown that bomedemstat, the treatment under study, caused some side effects in earlier studies. The most common were changes in taste, reported by about 36% of patients, and diarrhea, experienced by 34% of patients. These side effects are usually manageable. Bomedemstat also holds special approvals from the FDA for treating other conditions, indicating it has passed some safety checks. This background provides some confidence about its potential safety, but anyone considering joining the trial should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for polycythemia vera?

Bomedemstat is unique because it offers a new approach for treating polycythemia vera by targeting an enzyme called LSD1. Most current treatments for this condition, like phlebotomy or hydroxyurea, focus on reducing the number of red blood cells or controlling symptoms. In contrast, bomedemstat works by inhibiting LSD1, which plays a role in blood cell production, potentially providing a more direct way to manage the disease. Researchers are excited about bomedemstat because it could offer a more refined method to control blood cell levels, with possibly fewer side effects than existing therapies.

What evidence suggests that bomedemstat might be an effective treatment for polycythemia vera?

Research has shown that bomedemstat, a new type of medication, holds promise for treating polycythemia vera (PV). In earlier studies, 86% of patients experienced fewer symptoms, such as high blood cell counts. Additionally, 78% of patients saw a reduction in spleen size, a common issue with PV. Another study found that 83% of patients had stable or improved bone marrow conditions. Although researchers are still studying bomedemstat for PV, these results suggest it could be an effective treatment option. Participants in this trial will take bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if they derive clinical benefit. ^{1 2 3 5}

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 people with Polycythemia Vera who haven't responded well to at least one standard treatment. They should have a certain level of platelets and white blood cells, expect to live more than 36 weeks, and meet specific diagnostic criteria. Those with severe physical limitations, unresolved side effects from past treatments, certain infections or bleeding risks, pregnant or breastfeeding women, or on prohibited meds can't join.

Inclusion Criteria

My bone marrow fibrosis is minimal.

Has a life expectancy >36 weeks

I have tried at least one standard treatment to lower my blood volume without success.

Exclusion Criteria

I have HIV or active Hepatitis B/C.

I have an ongoing infection that isn't under control.

Is pregnant or lactating

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 36 weeks

36 weeks

Extended Treatment

Participants may receive additional treatment through Week 52 if deriving clinical benefit

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• bomedemstat

Trial Overview The study tests Bomedemstat (MK-3543), an oral drug that targets LSD1 enzymes in patients with Polycythemia Vera. The goal is to see if it's safe and can manage the disease by reducing blood counts, improving symptoms, and shrinking enlarged spleens within 36 weeks.

How Is the Trial Designed?

Group I: Bomedemstat Experimental Treatment 1 Intervention

Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

10

Recruited

380+

Imago BioSciences,Inc.

Lead Sponsor

Trials

10

Recruited

380+

Published Research Related to This Trial

The expert panel recommends starting cytoreductive drug therapy for patients with polycythaemia vera under 60 years old if they meet specific criteria, such as severe symptoms or high blood cell counts, to improve their quality of life and reduce vascular risks.

Ropeginterferon alfa-2b and ruxolitinib are recommended treatments, with ropeginterferon being the preferred option for patients needing cytoreductive therapy, especially those intolerant to phlebotomy or with inadequate control of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations. Marchetti, M., Vannucchi, AM., Griesshammer, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05558696

NCT05558696 | A Study of Bomedemstat (MK-3543) in ... This study will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1) ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06351631

NCT06351631 | A Study to Evaluate Safety and Efficacy of ... The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12559549/

Advances in polycythemia vera treatment with targeted ... in 86%, reduction in spleen size in 78%, stabilization or reduction in bone marrow in 83% and decrease of mutant allele burden in 42% along with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9431221/

P1051: A PHASE 2 STUDY OF IMG-7289 (BOMEDEMSTAT ... The most common non-hematologic AEs reported by patients was dysgeusia in 36% (32/90) and diarrhoea in 34% (31/90). All dysgeusia events were ...