Phase 2 N=90 Treatment

Bomedemstat (IMG-7289/MK-3543) in Participants With Myelofibrosis (IMG-7289-CTP-102/MK-3543-002)

Myelofibrosis · Post-polycythemia Vera Myelofibrosis (PPV-MF) · Post-essential Thrombocythemia Myelofibrosis (PET-MF) · Primary Myelofibrosis (PMF)

Bottom Line

View on ClinicalTrials.gov: NCT03136185 ↗

Enrolled (actual)

Serious AEs

48.9%

Results posted

Jan 2024

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bomedemstat (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Serious Adverse Events	4; 2; 5; 4; 4; 7	—
PRIMARY Number of Participants With Adverse Events	9; 3; 6; 8; 5; 11	—
PRIMARY Number of Participants That Discontinued Study Treatment Due To AEs	0; 1; 5; 1; 2; 4	—
PRIMARY Phase 1/2a Portion: Observed Maximum Concentration (Cmax) of Bomedemstat	12.63; 26.27	—
PRIMARY Phase 1/2a Portion: Time to Maximum Concentration (Tmax) of Bomedemstat	1.00; 1.05	—
PRIMARY Phase 1/2a Portion: Area Under the Concentration-time Curve of Bomedemstat From Time 0 to 24 Hours Post-dose (AUC0-24)	63.90; 265.92	—
PRIMARY Phase 1/2a Portion: Apparent Total Clearance (CL/F) of Bomedemstat After Oral Administration	12787.43; 3067.57	—
PRIMARY Percentage Change From Baseline in Spleen Volume	3.3; -13.7; 2.2; -9.1; -7.2; 0.3	—
PRIMARY Percentage Change From Baseline in Spleen Size	-36.5; 9.6; 24.1; 20.7; -28.1; 11.0	—

Summary

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (PK) and pharmacodynamics (PD) of a lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat (IMG-7289/MK-3543), administered orally once daily in participants with myelofibrosis. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (PMF), post-polycythaemia vera-myelofibrosis (PPVMF), and post-essential thrombocythaemia-myelofibrosis (PET-MF) (collectively referred to as 'MF'); inhibition of LSD1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.

Eligibility Criteria

Inclusion Criteria

>18 years of age
Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, or PPV-MF or PET-MF per the International Working Group for Myelofibrosis Research and Treatment
High or intermediate-2 risk disease

Exclusion Criteria

Receiving other treatments for the condition (with exceptions and time limits)
Major surgery in last 4 weeks, any surgery in the last 2 weeks
History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
History of splenectomy
Current use of prohibited medications
A concurrent second active and nonstable malignancy
Known human immunodeficiency virus infection or active Hepatitis B or Hepatitis C virus infection
Other hematologic/biochemistry requirements, as per protocol
Use of an investigational agent within last 14 days
Pregnant or lactating females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03136185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.