Hemab Therapeutics (Nasdaq: COAG) announced new clinical and preclinical data for its lead candidate, sutacimig, during the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The results from the Phase 2 long-term extension trial demonstrate a sustained reduction in bleeding episodes for patients with Glanzmann thrombasthenia (GT) and Factor VII deficiency (FVIID).
According to the company, participants in the study experienced a 62% reduction in high-intensity bleeding events that required transfusions or hospitalization. Furthermore, 92% of patients who experienced bleeds during the initial run-in period saw a decrease in their annualized treated bleeding rates (ATBR) while on sutacimig. The data also confirmed successful hemostatic outcomes for participants undergoing surgical or dental procedures.
Benny Sørensen, CEO of Hemab, noted that the findings support the company’s transition toward a Phase 3 trial, which is currently scheduled for the second half of 2026 following alignment with the U.S. Food and Drug Administration (FDA) on dosing regimens. Currently, there are no approved prophylactic treatments for GT, leaving many patients reliant on reactive care.
Preclinical data presented at the congress also indicated that sutacimig can restore thrombin generation in FVIID models, suggesting broad potential as a pan-hemostatic agent. While safety profiles remained generally manageable, the company reported that three participants experienced Grade 2 thromboembolic events, which were resolved with routine anticoagulation. Hemab continues to advance its broader pipeline, including HMB-002 for Von Willebrand disease and the HMB-003 program.