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HMB-001

Phase 1

Glanzmann Thrombasthenia | Small molecule | Other |Hemab Therapeutics Holdings, Inc.|Last Updated: Dec 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06211634A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann ThrombastheniaPHASE1 ACTIVE NOT_RECRUITING 57 — — Dec 13, 2022Aug 1, 2027Dec 24, 202517 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Part A: Safety as assessed by the incidence of treatment-emergent adverse events (TEAEs)
From baseline to Day 57
Part A: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
From baseline to Day 57
Part B: Safety as assessed by the incidence of treatment-emergent AEs
From baseline to Day 106/Early Termination (ET)/End of Study (EOS)
Part B: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
From baseline to Day 106/ET/EOS
Part B: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annualized bleed rate (ABR)
From baseline to Day 106/ET/EOS
Part B: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annualized treated bleed rate (ATBR)
From baseline to Day 106/ET/EOS
Part C: Safety as assessed by the incidence of treatment-emergent AEs
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)
Part C: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)
Part C: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annual treated bleed rate (ATBR) and annualized bleed rate (ABR)
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)
Secondary Endpoints
Part A: Plasma concentrations of HMB-001
From baseline to Day 57
Part A: Pharmacokinetics (PK) parameters: Maximum observed plasma concentration (Cmax)
From baseline to Day 57
Part A: PK parameters: Area under the curve from time zero to last quantifiable concentration (AUClast)
From baseline to Day 57
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Single or Multiple ascending dose of HMB-001EXPERIMENTALOpen-label, single or multiple ascending dose of HMB-001
Interventions
NameTypeDescription
HMB-001DRUGHMB-001 is a bispecific antibody being developed as a prophylactic treatment option to prevent and reduce bleeding events in patients with Glanzmann thrombasthenia.
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Eligibility Criteria
Age Range18 Years — 67 Years
SexALL
Healthy VolunteersNo
Study Sites17

Part A Inclusion Criteria: 1. Age 18 to 65 years, at the time of signing informed consent. 2. Glanzmann thrombasthenia; documented abnormal, diagnostic platelet aggregometry plus deficiency of the αIIbβ3 (GPIIb/GPIIIa) receptor via flow cytometry; or genetic diagnosis. 3. Has the ability to provide...

Countries:United StatesBelgiumFranceItalyNetherlandsUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06211634primaryCompletionDate: changed
LOWMay 24, 2026NCT06211634studyFirstPostDate: changed