Denmark-based clinical-stage biotechnology company Hemab Therapeutics, which is developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, announced on Tuesday clinical and preclinical results at the International Society on Thrombosis and Haemostasis (ISTH) 2025 Congress in Washington, DC.

The company's 11 abstracts present breakthrough data for sutacimig (formerly HMB-001) and HMB-002, its lead therapeutic candidates, along with crucial insights from natural history studies.

According to Hemab, sutacimig shows promising safety and efficacy in Glanzmann thrombasthenia (GT). The Phase 2 study is fully enrolled (N=34 in Part B), and data show a clinically meaningful reduction in treated bleeding events.

A late breaking abstract presentation of HMB-002 demonstrates positive proof of mechanism in Von Willebrand disease (VWD), with the first-in-human VELORA Pioneer study in Type 1 VWD patients.

Sutacimig is a subcutaneously administered bispecific antibody that binds and stabilises endogenous Factor VIIa with one antibody arm and binds to TLT-1 on activated platelets with the other arm. This mechanism allows for the accumulation of endogenous Factor VIIa in the body and recruitment of Factor VIIa directly to the surface of the activated platelets, where it facilitates haemostatic plug formation. Sutacimig is designed to be a first-in-class prophylactic treatment for GT with the potential to treat other bleeding disorders. The US Food and Drug Administration has granted Fast Track Designation and Orphan Drug Designation to sutacimig for the treatment of GT, while the UK Medicines and Healthcare products Regulatory Agency has awarded it designation under the Innovative Licensing and Access Pathway (ILAP).