GlobeNewswire·Jul 14, 2026, 7:45 AM ET

Hemab Therapeutics Presents Clinical and Preclinical Data from Sutacimig in Glanzmann Thrombasthenia and Factor VII Deficiency at the ISTH 2026 Congress

COAG

Hemab Therapeutics presented clinical & preclinical data on sutacimig, HMB-002, & HMB-003 at ISTH 2026 in Paris.
Sutacimig Phase 2 long-term extension data show sustained bleed reduction & manageable safety/tolerability across 34 patients.
FDA alignment confirmed for a Phase 3 dose & regimen of 0.2mg/kg administered weekly.
Phase 3 initiation for sutacimig is planned for the second half of 2026.
Sutacimig reduced mean annualized treated bleeding rate (ATBR) by approximately 84% in the low-dose weekly cohort.
High-intensity bleeding events were reduced by 62% in patients with prior severe bleeding requiring transfusions or hospitalization.
First surgical use data demonstrated successful hemostatic outcomes in three participants undergoing procedures.
Safety profile was manageable with predominantly mild to moderate adverse events; three Grade 2 thromboembolic events occurred but were resolved.
Preclinical data for sutacimig in Factor VII deficiency demonstrate restored thrombin generation under disease-mimicking conditions.
Natural history studies confirm a lifelong bleeding burden in Glanzmann thrombasthenia, with over 90% of young adults bleeding weekly.
Prophylaxis is critically underutilized in Glanzmann thrombasthenia, with only 14% of patients receiving preventive treatment.
Psychological burden is significant in Glanzmann thrombasthenia, with depressive symptoms occurring 3-4x more frequently than in the general population.
HMB-002 data were presented for Von Willebrand disease, while HMB-003 program details were announced as a novel anti-fibrinolytic.
Sutacimig holds Fast Track, Orphan Drug, & Breakthrough Therapy designations from the FDA for Glanzmann thrombasthenia.