Clinical Read2026-09-18

HMB-003

Hemab Therapeutics Holdings Inc.COAG
Indication
Heavy menstrual bleeding
Stage
phase1
Event
Phase 1
Details

Sept. 17, 2026: Hemab Therapeutics (NASDAQ: COAG) announced dosing of the first healthy volunteer in a Phase 1 trial of HMB-003 for heavy menstrual bleeding. HMB-003 is a subcutaneous peptide-based plasmin inhibitor designed to stabilize clots and reduce bleeding by directly inhibiting plasmin independently of the plasminogen activation pathway.

The Phase 1 study (NCT07798505) is a randomized, placebo-controlled, single-ascending-dose escalation trial in healthy adults evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. The company said results are expected no later than mid-2027 and will inform dose selection and broader clinical development plans, including other bleeding conditions.

Preclinical data cited in the release showed greater activity than tranexamic acid in evaluated models; in minipigs, a single subcutaneous dose reached peak plasma levels within hours and maintained antifibrinolytic activity for about one week, supporting potential once-per-cycle dosing.

Hemab also said HMB-003 is being explored beyond heavy menstrual bleeding for other bleeding settings including hereditary hemorrhagic telangiectasia and peri-operative bleeding management.