Hemab Therapeutics (NASDAQ: COAG) has dosed its first participant in a Phase 1 clinical trial of HMB-003, an investigational treatment for heavy menstrual bleeding.
The randomized, placebo-controlled trial — registered under identifier NCT07798505 — will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-ascending doses of HMB-003 in healthy adult volunteers, the company said.
HMB-003 is a fatty-acid-conjugated peptide antifibrinolytic designed to stabilize clots and reduce bleeding by directly inhibiting plasmin at its active site, blocking fibrinolysis independently of the plasminogen activation pathway. According to preclinical studies in minipigs, a single subcutaneous dose achieved peak plasma levels within hours and sustained antifibrinolytic activity for approximately one week, supporting the possibility of once-per-cycle dosing in patients. Results from the Phase 1 study are expected no later than mid-2027.
Heavy menstrual bleeding affects roughly one in three reproductive-aged women, according to the American College of Obstetricians and Gynecologists. It is a leading cause of iron deficiency and anemia among premenopausal women and a primary driver of hysterectomies in the United States. Current treatment options include tranexamic acid, which requires frequent dosing throughout menstruation, and hormonal therapies. No approved non-hormonal, long-acting treatment currently exists for the condition.
"Dosing our first participant with HMB-003, purpose-built for the management of heavy menstrual bleeding, is the first step toward resetting the standard of care for these women," said CEO Benny Sørensen.
Hemab, based in Cambridge, Massachusetts, with operations also in Copenhagen, Denmark, is a clinical-stage biotechnology company developing therapies for blood coagulation disorders. Its pipeline also includes sutacimig, being studied for Glanzmann thrombasthenia and Factor VII deficiency, and HMB-002, being developed for Von Willebrand Disease.
