GlobeNewswire·Sep 17, 2026, 8:00 AM ET

Hemab Therapeutics Announces First Participant Dosed in Phase 1 Clinical Trial of HMB-003, an Investigational Therapy for the Management of Heavy Menstrual Bleeding

COAG

Hemab Therapeutics dosed its first healthy volunteer in a Phase 1 clinical trial for HMB-003, an investigational therapy for heavy menstrual bleeding.
HMB-003 is a fatty-acid-conjugated peptide antifibrinolytic engineered to directly inhibit plasmin at its active site to stabilize clots & reduce bleeding.
Preclinical studies in minipigs showed a single subcutaneous dose of HMB-003 achieved peak plasma levels within hours & sustained antifibrinolytic activity for approximately one week.
HMB-003 demonstrated greater activity than tranexamic acid in preclinical models & aims to enable once-per-cycle dosing to improve upon current short-acting therapies.
Heavy menstrual bleeding affects approximately 1 in 3 reproductive-aged women, totaling about 23 million seeking care in the U.S. last year.
The condition is the leading cause of iron deficiency & anemia among premenopausal women & drives a significant portion of the roughly 600,000 annual hysterectomies in the U.S.
Data indicates heavy menstrual bleeding is 10 times more prevalent than asthma & diabetes in the same population & causes over $94 billion in annual U.S. economic costs.
The Phase 1 trial (NCT07798505) is a randomized, placebo-controlled, single-ascending-dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, & pharmacodynamics.
Hemab Therapeutics expects to share results from the Phase 1 study to inform clinical development plans no later than mid-2027.
Current treatment options are limited by the short half-life of tranexamic acid or the unsuitability of hormonal therapies for many women.
HMB-003 is being developed to address bleeding across multiple indications including heavy menstrual bleeding, hereditary hemorrhagic telangiectasia, & peri-operative bleeding management.