Hemab Therapeutics reported new ISTH 2026 data across three rare bleeding disorder programs, including first‑in‑human proof for HMB‑002 in Von Willebrand disease, long‑term efficacy of sutacimig in Glanzmann thrombasthenia, and the debut of HMB‑003 plasmin inhibitor.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Hemab Therapeutics has reported new clinical and preclinical findings across three investigational programs at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress, highlighting progress in therapies for rare bleeding disorders. The updates include positive first-in-human data for HMB-002 in Von Willebrand disease (VWD), long-term efficacy results for sutacimig in Glanzmann thrombasthenia (GT), and the debut of HMB-003, a novel peptide plasmin inhibitor that will enter first-in-human studies in the second half of 2026.
The company’s lead program, sutacimig, also recently received both U.S. FDA Breakthrough Therapy designation and European Medicines Agency (EMA) PRIME designation, with a Phase 3 trial expected to begin later this year.
HMB-002 validates mechanism in Von Willebrand disease
New first-in-human data from HMB-002 demonstrated proof of mechanism by increasing endogenous Von Willebrand Factor (VWF) and Factor VIII (FVIII) levels after subcutaneous administration. Multiple-dose evaluation is currently underway to further assess durability and clinical benefit.
HMB-002 is a monoclonal antibody developed as a preventive treatment for VWD. Rather than replacing missing clotting factors, it binds the C-terminal CK domain of VWF, protecting the protein from degradation and increasing naturally circulating VWF without interfering with its normal function.
VWD is the most common inherited bleeding disorder and is caused by reduced levels or impaired function of VWF. Patients frequently experience recurrent nosebleeds, easy bruising, prolonged bleeding, and heavy menstrual bleeding, while current therapies largely provide temporary symptom control.
The HMB-002 clinical program includes two ongoing studies (NCT06610201 and NCT06754852).
Long-term sutacimig data support Phase 3 development
Updated long-term extension data from the ongoing Phase 2 study (NCT06211634) showed that sutacimig continued to reduce annualized treated bleeding rates (ATBR) in patients with Glanzmann thrombasthenia. Investigators also reported successful use of the therapy during surgical procedures, suggesting consistent bleeding protection over extended treatment.
Supporting presentations included real-world and natural history analyses that highlighted the significant clinical burden of GT, a rare inherited platelet disorder with no approved preventive therapies. Additional preclinical data also supported expansion of sutacimig into Factor VII deficiency, where a Phase 2 proof-of-concept study is ongoing, with results expected in late 2026 or early 2027.
Sutacimig is a subcutaneous bispecific antibody that stabilizes endogenous Factor VIIa while directing it to activated platelets, promoting effective clot formation without routine factor replacement.
Hemab introduces HMB-003
Hemab also introduced HMB-003, a long-acting peptide-based plasmin inhibitor developed to reduce excessive bleeding across multiple conditions. The candidate directly blocks plasmin activity, preventing clot breakdown independently of the plasminogen activation pathway.
The therapy incorporates fatty acid conjugation to extend its half-life and support subcutaneous dosing. Initial clinical studies are scheduled to begin during the second half of 2026, while development in heavy menstrual bleeding is planned to start in 2027. Additional future indications may include hereditary hemorrhagic telangiectasia and perioperative bleeding management.
Clinical Implications
Chief Executive Officer Benny Sørensen, MD, PhD, said many patients with severe coagulation disorders continue to face unpredictable bleeding episodes despite available treatments. He noted that the latest findings strengthen clinical validation of HMB-002, support sutacimig’s advancement into Phase 3, and expand the company’s pipeline with HMB-003, targeting several high unmet-need bleeding conditions.
Path Forward
Hemab expects to initiate the Phase 3 trial of sutacimig in GT during the second half of 2026 following its recent FDA Breakthrough Therapy and EMA PRIME designations. Multiple-dose evaluation of HMB-002 is ongoing, while first-in-human testing of HMB-003 will begin later this year. Together, the three programs reflect the company’s strategy to develop long-acting, subcutaneous therapies that address major unmet needs across inherited and acquired bleeding disorders.
Reference
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.